Unobtrusive Nasal Mask

ABSTRACT

A patient interface for delivering breathable gas to a patient includes a sealing portion including a nose tip engagement portion adapted to form a seal with the patient&#39;s nose tip, an upper lip engagement portion adapted to form a seal with the patient&#39;s upper lip and/or base of the patient&#39;s nares, and nostril engagement flaps adapted to form a seal with the patient&#39;s nares. The nose tip engagement portion, the upper lip engagement portion, and the nostril engagement flaps are all structured to extend or curve outwardly from a supporting wall defining an air path.

CROSS-REFERENCE TO APPLICATIONS

This application is a continuation of U.S. application Ser. No.14/738,977, now allowed, filed Jun. 15, 2015, which is a continuation ofU.S. application Ser. No. 13/321,981, filed Nov. 22, 2011, now issued asU.S. Pat. No. 9,095,673, which is the U.S. national phase ofInternational Application No. PCT/AU2010/000684, filed Jun. 2, 2010,which designated the U.S. and claims the benefit of AustralianProvisional Application No. 2009902524, filed Jun. 2, 2009; AustralianProvisional Application No. 2009906101, filed Dec. 15, 2009; AustralianProvisional Application No. 2010902359, filed May 28, 2010; U.S.Provisional Application 61/222,711, filed Jul. 2, 2009; U.S. ProvisionalApplication 61/272,162, filed Aug. 25, 2009; U.S. ProvisionalApplication 61/272,250, filed Sep. 4, 2009; U.S. Provisional Application61/263,175, filed Nov. 20, 2009; U.S. Provisional Application61/282,693, filed Mar. 18, 2010; and PCT Application No.PCT/AU2010/000657, filed May 28, 2010, each of which is incorporatedherein by reference in its entirety.

FIELD OF THE INVENTION

The technology relates to a nasal respiratory mask for use with an airdelivery system for treatment, e.g., of Sleep Disordered Breathing (SDB)with Continuous Positive Airway Pressure (CPAP) or Non-Invasive PositivePressure Ventilation (NIPPY). In particular, the technology relates to arespiratory mask that is unobtrusive.

BACKGROUND OF THE INVENTION

Apparatus to deliver breathable gas to a patient typically includes apositive airway pressure (PAP) device, an air delivery conduit or tube,and a patient interface, wherein the patient interface contacts thepatient's face in use to deliver pressurized breathable gas to thepatient from the PAP device.

In use, the patient interface can appear bulky and as such maydiscourage patients from using treatment as it is too obtrusive. This inturn may lead to lower therapy compliance and thus failed treatment.

Patients using nasal pillows or puffs may dislike the placement of thepillows in the nares and/or the sensation of pressurized air beingdirected up the nares (also known as the ‘air jetting’ affect).

Therefore, a need has developed in the art to provide alternativepatient interfaces that are less obtrusive, may not include placement ofpillows up the nares and/or may reduce the sensation of pressurized airbeing directed up the nares.

SUMMARY OF THE INVENTION

One aspect of the present technology relates to a patient interface fordelivering breathable gas to a patient. Another aspect of the presenttechnology is a patient interface that forms a seal on an underside of apatient's nose. Another aspect of the present technology is a patientinterface that avoids contact with a nasal bridge region of a patient'snose. Another aspect of the present technology is a patient interfacethat forms a seal on an underside of a patient's nose in a regionsurrounding both nares. Another aspect of the present technology is apatient interface that avoids contacting the nasal septum. Anotheraspect of the present technology is a patient interface defining asingle breathing chamber that provides a supply of air at positivepressure for both nostrils.

One form of patient interface in accordance with the present technologyincludes a sealing portion including a nose tip engagement portionadapted to form a seal with the patient's nose tip, an upper lipengagement portion adapted to form a seal with the patient's upper lipand/or base of the patient's nares, and nostril engagement flaps adaptedto form a seal with the patient's nares. In one form, the nose tipengagement portion, the upper lip engagement portion, and the nostrilengagement flaps are all structured to extend or curve outwardly from asupporting wall defining an air path.

In accordance with one form of the present technology, a patientinterface is provided that makes use of different seal-formingmechanisms in different regions of the patient interface. Preferably, ina region adapted to form a seal with a nasal crease region of a face, aportion of the seal acts in compression. Preferably, in a region adaptedto form a seal with a tip of the nose region of a face, a portion of theseal acts in tension in use. Preferably in an alar sidewall regionintermediate of the crease region of the face and a tip of the noseregion of a face, a seal portion of the patient interface is arranged toform a cantilever. Preferably in a region intermediate of a left creaseregion and a right crease region of a face, a seal portion of thepatient interface is constructed and arranged to be in tension in use.

In accordance with one form of the present technology, a patientinterface is provided that includes a nose tip seal forming portion inthe form of a membrane. Preferably the membrane is constructed andarranged to be held relatively fixed at its ends and in tension againsta tip of a nose in use.

In accordance with one form of the present technology, a patientinterface is provided that comprises a seal forming portion constructedand arranged to have regions of different stiffnesses. In one form, theseal forming portion has a region of relatively high stiffness arrangedin use adjacent a nasal crease region of the face, or adjacent the baseof the nose near the junction between the top lip and a side of thenose. In one form, the seal forming portion may include respective leftand right regions of relatively high stiffness. In one form, the sealforming portion includes a region of relatively low stiffness adapted toform a seal on an underside of a tip of the nose region of a face. Inone form, the seal forming portion has a region of intermediatestiffness arranged in use adjacent a side portion of a nose.

In one form, a seal forming portion of a patient interface in accordancewith the present technology defines front and rear lateral portions onboth a left side and a right side. In one form, a seal forming portionof a patient interface in accordance with the present technology definesfront and rear medial portions. Preferably, the respective left andright lateral portions are constructed and arranged to hinge about thefront and rear medial portions in use. With reference to FIGS. 19 to 21of International Patent Application PCT/AU2004/000207 published as WO2004/073778, a seal forming portion in accordance with an aspect of thepresent technology is adapted to hinge about a medial portion toaccommodate an alar angle of a patient. In one form, the sealing portionis adapted to hinge outwardly to accommodate a wider nose. In one formthe sealing portion is adapted to hinge inwardly to accommodate anarrower nose.

In one form of the present technology, a patient interface is providedthat includes headgear and a seal forming portion. The seal formingportion is adapted to flex about a medial portion thereof to define anangle therebetween. The patient interface is constructed and arranged sothat the angle may be adjusted by altering a headgear tension. In oneform, the patient interface includes lateral headgear connectorsarranged at an angle with respect to an orifice through which a supplyof breathable gas is delivered to the patient. The patient interface isconstructed and arranged in one form so that the angle of the headgearconnector is adjustable. In a preferred form, adjustment of the angle ofthe headgear connector may be used to adjust an angle of theseal-forming portion. In one form, adjustment of headgear may be used toincrease or decrease a lateral or pinch force of a seal-forming portion.In one form, headgear is connected close to an underside of aseal-forming portion. Preferably the patient interface is arranged sothat flexure of a seal-forming portion about a medial portion thereofmay be achieved by altering a headgear tension. In one form, a topsurface of a headgear connector is configured to push against anunderside of a seal-forming portion, preferably a rear-lateral portionthereof, to increase a lateral or pinch force.

In one form, a patient interface is provided that includes aseal-forming portion adapted to form a seal on an underside of a nose ofa patient, the patient interface includes a flexible body that defines abreathing chamber. Headgear is connected to sides of the flexible body.The body is constructed and arranged to flex in response to a changedheadgear tension to alter a lateral or pinch force on a side of a noseto effect a seal. In one form the flexible body is formed from a rubber,preferably silicone. In one form the flexible body is formed from arubber having a Type A durometer of about 35 to about 45, preferablyabout 40.

In one form of the present technology, a patient interface is providedthat comprises a seal forming portion, headgear, an air delivery conduitand a decoupling arrangement. The headgear is connected to a region ofthe patient interface close to the seal forming portion. The airdelivery conduit is connected to the decoupling portion. The decouplingportion is located between a point of connection of the headgear and apoint of connection of the air delivery conduit.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient, the patient interfaceincluding a sealing portion structured to extend or curve outwardly froma supporting wall defining an air path. In one form of the presenttechnology, a seal-forming portion is arranged in a trumpet or hornshape in cross-section. In one form, a seal-forming portion has abell-shape in cross-section. In one form, a seal-forming portion lies onan inside surface of a cushion. In one form, certain regions of the sealforming portion have a trumpet, horn or bell shape, while other regionshave a different shape. For example, a region of the seal formingportion adapted to form a seal with an underside of a tip of the nosemay have a trumpet, horn or bell shape.

In one form of the present technology, a seal forming portion is formedfrom a low durometer rubber, preferably a silicone having a Type Adurometer in the range of 1 to 15.

In one form of the present technology, a patient interface is providedthat comprises a mask body formed from a rubber having a Type Adurometer in the range of about 35 to about 45, and a seal-formingportion formed from a rubber having a Type A durometer in the range of 1to 15. In one form, the patient interface further comprises headgearconnectors formed from a flexible material, preferably a rubber having aType A durometer in the range of about 35 to about 45. Preferably therubber is silicone rubber.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient, the patient interfaceincluding a sealing portion structured to curve outwardly and form atleast one hanging membrane.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion including a nose tip engagement portionadapted to form a seal with the patient's nose tip, an upper lipengagement portion adapted to form a seal with the patient's upper lipand/or base of the patient's nares, and nostril engagement flaps adaptedto form a seal with the patient's nares, and a supporting portionsupporting one or more portions of the sealing portion, wherein thesupporting portion supports different portions of the sealing portionwith varying degrees of support. The supporting portion may include oneor more thickened portions, have cored out portion or recesses, orportions having variable hardness to provide the varying degrees ofsupport.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient, a supporting portionsupporting one or more portions of the sealing portion, wherein thesupporting portion supports different portions of the sealing portionwith varying degrees of support.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion including a nose tip engagement portionadapted to form a seal with the patient's nose tip, an upper lipengagement portion adapted to form a seal with the patient's upper lipand/or base of the patient's nares, and nostril engagement flaps adaptedto form a seal with the patient's nares, and a supporting portionsupporting the sealing portion, the sealing portion being connected tothe supporting portion on side portions of the sealing portion, and thesealing portion being spaced apart from the supporting portion on frontand rear portions of the sealing portion.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion including a nose tip engagement portionadapted to form a seal with the patient's nose tip, an upper lipengagement portion adapted to form a seal with the patient's upper lipand/or base of the patient's nares, and nostril engagement flaps adaptedto form a seal with the patient's nares, and a supporting portionsupporting the sealing portion, the sealing portion being connected tothe supporting portion, and the sealing portion being attached to thesupporting portion, wherein the supporting portion is compliant.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion and a supporting portion supporting thesealing portion, the sealing portion being connected to the supportingportion in some regions, and being spaced apart from the supportingportion in other regions.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion including a nose tip engagement portionadapted to engage with the patient's nose tip, and a supporting portionsupporting the sealing portion, the supporting portion being connectedto the sealing portion on two side portions of the sealing portion, andthe supporting portion being spaced apart by a gap from the sealingportion at the nose tip engagement portion, the nose tip engagementportion being adapted to stretch to fit and seal with the patient's nosetip.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion adapted to form a seal with a patient's facein use, the sealing portion including a front stretch portion adapted toform a seal with the patient's nose tip, a rear stretch portion adaptedto for a seal with the patient's upper lip, side push portions adaptedto anchor the sealing portion at regions of the patient's nose adjacentthe nasal labial creases by applying a force normal to a plane of thepatient's face, and side wrap portions adapted to form a seal with thepatient's nares by applying a pinching force normal to the patientsnares. The side wrap portions and side push portions may have a greaterthickness than the front stretch portion or the rear stretch portion.The front stretch portion may stretch to seal with the patient's nosetip in use and the rear stretch portion may stretch to seal with thepatient's upper lip in use.

Another aspect of the present technology relates to a patient interfacefor delivering pressurized breathable gas to a patient. The patientinterface includes a sealing portion adapted to form a seal with thepatient's face, the sealing portion having an opening adapted to receivethe pressurized breathable gas, an outer sealing margin to seal with thepatient's face, and a transition region between the opening and theouter sealing margin that gradually increases in size from the openingto the outer sealing margin.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion adapted to form a seal with the patient'sface, a supporting portion supporting one or more portions of thesealing portion, headgear connectors extending from the supportingportion, the headgear connectors adapted to connect to headgear tosecure the patient interface to the patient, wherein the headgear causesthe headgear connectors to bend towards the supporting portion in use,and a bending force from the headgear connectors is transferred to thesealing portion as a sealing force. The bending force may be applied asa pinch force to sides of the patient's nose, and/or as an anchor forceto regions of the patient's nose adjacent the nasal labial creases.

Another aspect of the present technology relates to a patient interfacefor delivering breathable gas to a patient. The patient interfaceincludes a sealing portion, and a multi-axis elbow assembly operativelycoupled between the sealing portion and a flexible tube, wherein themulti-axis elbow assembly allows movement of the flexible tube in twoseparate planes while substantially isolating drag forces from theflexible tube from being transferred to the sealing portion.

Another aspect of the present technology relates to a multi-axis elbowassembly that allows movement of a connected tube in two separate planeswhile substantially isolating drag forces from the tube.

Other aspects, features, and advantages of the present technology willbecome apparent from the following detailed description when taken inconjunction with the accompanying drawings, which are a part of thisdisclosure and which illustrate, by way of example, principles of thistechnology.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings facilitate an understanding of the variousembodiments of this technology. In such drawings:

FIG. 1 shows a PAP system with a prior art patient interface;

FIG. 1-1 shows a patient interface according to an embodiment of thetechnology in use;

FIG. 1-2 is an isometric view of a sealing portion and suspension systemof the patient interface of FIG. 1-1;

FIG. 1-3 is another isometric view of the sealing portion and suspensionsystem of FIG. 1-2;

FIG. 1-4 is a top view of the sealing portion and suspension system ofFIG. 1-2;

FIG. 1-5 is a bottom view of the sealing portion and suspension systemof FIG. 1-2;

FIG. 1-6 is a front view of the sealing portion and suspension system ofFIG. 1-2;

FIG. 1-7 is a rear view of the sealing portion and suspension system ofFIG. 1-2;

FIG. 1-8 is a side view of the sealing portion and suspension system ofFIG. 1-2;

FIG. 1-9 is an isometric view of a suspension system and frame of thepatient interface of FIG. 1-1;

FIG. 1-10 is a bottom view of the suspension system and frame of FIG.1-9;

FIG. 1-11 is a top view of the suspension system and frame of FIG. 1-9;

FIG. 1-12 is a front view of the suspension system and frame of FIG.1-9;

FIG. 1-13 is a rear view of the suspension system and frame of FIG. 1-9;

FIG. 1-14 is a side view of the suspension system and frame of FIG. 1-9;

FIG. 1-15 is an isometric view of a sealing portion, suspension system,and frame of the patient interface of FIG. 1-1;

FIG. 1-16 is a rear view of the sealing portion, suspension system, andframe of FIG. 1-15;

FIG. 1-17 is a front view of the sealing portion, suspension system, andframe of FIG. 1-15;

FIG. 1-18 is a side view of the sealing portion, suspension system, andframe of FIG. 1-15;

FIG. 2-1 is a rear view of a sealing portion and frame according to anembodiment of the present technology;

FIG. 2-2 is a front view of the sealing portion and frame of FIG. 2-1;

FIG. 2-3 is a side view of the sealing portion and frame of FIG. 2-1;

FIG. 2-4 is a top view of the sealing portion and frame of FIG. 2-1;

FIG. 2-5 is a bottom view of the sealing portion and frame of FIG. 2-1;

FIG. 2-6 is an isometric view of the sealing portion and frame of FIG.2-1;

FIGS. 2-7A and 2-7B are top views illustrating alternative shapes of thesealing portion according to embodiments of the present technology;

FIGS. 2-8A and 2-8B are side views illustrating alternative shapes ofthe sealing portion according to embodiments of the present technology;

FIGS. 2-9A and 2-9B are rear views illustrating alternative shapes ofthe sealing portion according to embodiments of the present technology;

FIG. 2-10 is an isometric view of a sealing portion and frame in useaccording to an embodiment of the present technology;

FIG. 2-11 is a rear view illustrating an alternative shape of thesealing portion according to an embodiment of the present technology;

FIG. 3-1 shows a patient interface according to another embodiment ofthe technology in use;

FIG. 3-2 is an isometric view of a sealing portion and suspension systemof the patient interface of FIG. 3-1;

FIG. 3-3 is a rear view of the sealing portion and suspension system ofFIG. 3-2;

FIG. 3-4 is a top view of the sealing portion and suspension system ofFIG. 3-2;

FIG. 3-5 is a bottom view of the sealing portion and suspension systemof FIG. 3-2;

FIG. 3-6 is a side view of the sealing portion and suspension system ofFIG. 3-2;

FIG. 4-1 shows a patient interface according to another embodiment ofthe technology in use;

FIG. 4-2 is an isometric view of a sealing portion of the patientinterface of FIG. 4-1;

FIG. 4-3 is another isometric view of the sealing portion of FIG. 4-2;

FIG. 4-4 is a rear view of the sealing portion of FIG. 4-2;

FIG. 4-5 is a front view of the sealing portion of FIG. 4-2;

FIG. 4-6 is a side view of the sealing portion of FIG. 4-2;

FIG. 4-7 is a top view of the sealing portion of FIG. 4-2;

FIGS. 4-8 and 4-9 show alternative self-adjusted shapes of the sealingportion of FIG. 4-2;

FIGS. 5-1 and 5-2 are cross-sectional views illustrating sealingportions with gel beading according to embodiments of the presenttechnology;

FIGS. 6-1 and 6-2 are schematic views illustrating nostril engagementflaps for sealing portions according to embodiments of the presenttechnology;

FIGS. 7-1, 7-2, and 7-3 show sealing portions with fingers or ridgesaccording to embodiments of the present technology;

FIG. 8-1 illustrates a mask with a gel suspension system according to anembodiment of the present technology;

FIGS. 8-2 and 8-3 show a mask with a gel suspension system according toanother embodiment of the present technology;

FIGS. 9-1 and 9-2 show sealing portions with stiffening ribs accordingto embodiments of the present technology;

FIG. 10 shows a sealing portion with headgear connectors according to anembodiment of the present technology;

FIG. 11 shows a suspension system with headgear connectors according toan embodiment of the present technology;

FIG. 12 shows headgear for a mask according to an embodiment of thepresent technology;

FIGS. 13-1, 13-2, 13-3, 13-4, and 13-5 shows headgear according to anembodiment of the present technology;

FIGS. 14-1, 14-2, 14-3, and 14-4 show elbows for a mask according toembodiments of the present technology;

FIG. 15 shows a sealing portion with adhesive strips according to anembodiment of the present technology;

FIGS. 16-1 and 16-2 show sealing portions with flexible tubing accordingto embodiments of the present technology;

FIGS. 17-1 and 17-2 illustrate sealing portions with a gusset-typesuspension system according to embodiments of the present technology;

FIGS. 18-1 and 18-2 illustrate a sealing portion provided to anexoskeleton according to an embodiment of the present technology;

FIG. 19 illustrates a gel sealing portion according to an embodiment ofthe present technology;

FIGS. 20-1 to 20-7 show cross sections of a sealing portion according toan embodiment of the present technology;

FIG. 21-1 is a side view of a lower portion of an embodiment of thepresent technology;

FIG. 21-2 is a rear view of a lower portion of an embodiment of thepresent technology;

FIG. 21-3 is a front view of a lower portion of an embodiment of thepresent technology;

FIG. 21-4 is a top view of a lower portion of an embodiment of thepresent technology;

FIG. 21-5 is another top view of a lower portion of an embodiment of thepresent technology;

FIG. 21-6 is a bottom view of a lower portion of an embodiment of thepresent technology;

FIG. 22-1 is a side view of an upper portion of an embodiment of thepresent technology;

FIG. 22-2 is a rear view of an upper portion of an embodiment of thepresent technology;

FIG. 22-3 is a front view of an upper portion of an embodiment of thepresent technology;

FIG. 22-4 is a top view of an upper portion of an embodiment of thepresent technology;

FIG. 23-1 is a side view of an embodiment of the present technology;

FIG. 23-2 is a rear view of an embodiment of the present technology;

FIG. 23-3 is a front view of an embodiment of the present technology;

FIG. 23-4 is a top view of an embodiment of the present technology;

FIG. 23-5 is a bottom view of an embodiment of the present technology;

FIG. 23-6 is a cross section through a side view of an embodiment of thepresent technology;

FIG. 23-7 is a cross section through a front view of an embodiment ofthe present technology;

FIG. 24-1 is a top view of a sealing portion according to an embodimentof the present technology;

FIGS. 24-2 and 24-3 are front views of the sealing portion of FIGS.24-1;

FIG. 24-4 is bottom view of the sealing portion of FIGS. 24-1;

FIGS. 25-1, 25-2 and 25-3 are cross sections of sealing portionsaccording to alternative embodiments of the present technology;

FIG. 25-4 is a top view of a sealing portion according to an embodimentof the present technology;

FIG. 26 is a side view of a decoupling arrangement according to anembodiment of the present technology;

FIGS. 27-1 and 27-2 are isometric views of an embodiment of the presenttechnology;

FIG. 28 is an isometric view of a sealing portion with sizing optionsaccording to an embodiment of the present technology;

FIG. 29 is a cross section of a prior art sealing portion;

FIG. 30 is a cross section of a prior art sealing portion;

FIG. 31 is a cross section of a sealing portion according to anembodiment of the present technology;

FIG. 32-1 is a rear view showing headgear attachment to a sealingportion according to an embodiment of the present technology;

FIG. 32-2 is a front view showing headgear attachment to a sealingportion according to another embodiment of the present technology;

FIGS. 33-1 and 33-2 are top views of supporting members for sealingportions according to alternative embodiment of the present technology;

FIGS. 34-1 and 34-2 show membrane support for a sealing portionaccording to an embodiment of the present technology;

FIG. 35-1 is a top view of a sealing portion with flexible portionsaccording to an embodiment of the present technology;

FIGS. 35-2 and 35-3 are cross-sectional views of the sealing portion ofFIG. 35-1;

FIG. 36 is a side view of a membrane support according to an embodimentof the present technology;

FIGS. 37-1 and 37-2 illustrate a vent according to an embodiment of thepresent technology;

FIG. 38 is a side view of an elbow according to an embodiment of thepresent technology;

FIG. 39 is an isometric views of support mechanism for a stem of thesealing portion according to an embodiment of the present technology;

FIG. 40 is a cross section of a sealing portion according to anembodiment of the present technology;

FIG. 41 is a side view of a tube decoupling mechanism according to anembodiment of the present technology;

FIG. 42-1 is a top view of a swivel ring with vents according to anembodiment of the present technology;

FIG. 42-2 is an isometric view of the swivel ring of FIG. 42-1;

FIG. 42-3 is a side view of a swivel ring according to an embodiment ofthe present technology;

FIGS. 42-4, 42-5, 42-6 and 42-7 are top views of swivel rings includingvents according to alternative embodiments of the present technology;

FIG. 42-8 is a cross section of the swivel ring of FIG. 42-7;

FIG. 43 is a side view of a system including a plenum according to anembodiment of the present technology;

FIGS. 44 to 46 show sealing of a sealing portion with a patient's noseaccording to an embodiment of the present technology;

FIGS. 47-1, 47-2 and 47-3 are isometric views of a patient interfaceaccording to the present technology including a sealing portion and asupporting portion;

FIG. 48-1 is a top view of the sealing portion and supporting portion ofFIG. 47-1;

FIG. 48-2 is a schematic top view of the sealing portion of FIG. 47-1;

FIG. 49 is a front view of the sealing portion and supporting portion ofFIG. 47-1;

FIG. 50 is a rear view of the sealing portion and supporting portion ofFIG. 47-1;

FIG. 51-1 is a cross-sectional side view of the sealing portion andsupporting portion of FIG. 49;

FIG. 51-2 is a cross-sectional side view of the sealing portion andsupporting portion of FIG. 49, with a second membrane;

FIG. 52-1 is a side view of the supporting portion of FIG. 47-1;

FIG. 52-2 is a cross-sectional front view of the sealing portion andsupporting portion of FIG. 49;

FIG. 52-3 is a partial cross-sectional front view of the sealing portionand supporting portion of FIG. 49;

FIG. 52-4 is a cross-sectional side view of the sealing portion andsupporting portion of FIG. 49 on the patient in use;

FIG. 52-5 is a side view of the sealing portion and supporting portionof FIG. 49 on the patient in use;

FIG. 52-6 is a cross-sectional side view of the sealing portion andsupporting portion of FIG. 49 on the patient in use;

FIG. 52-7 is a front perspective view of the sealing portion andsupporting portion of FIG. 49 on the patient in use;

FIG. 53 is a front view of the supporting portion of FIG. 47-1;

FIG. 54 is a front view of the supporting portion of FIG. 47-1 andheadgear connectors;

FIG. 55 is a top view of the supporting portion and headgear connectorsof FIG. 54;

FIG. 56-1 is a side view of the supporting portion and headgearconnectors of FIG. 54;

FIG. 56-2 is a cross-sectional view of the supporting portion of FIG.54;

FIG. 56-3 is a cross-sectional view of the supporting portion of FIG.54;

FIG. 57 is a front perspective view of a patient interface according toan embodiment of the present technology;

FIG. 58 is a front perspective view of a patient interface in a bentposition according to an embodiment of the present technology;

FIG. 59 is a perspective view of a multi-axis elbow assembly accordingto an embodiment of the present technology;

FIG. 60 is a right side perspective view of a patient interface on thepatient in use according to an embodiment of the present technology;

FIG. 61 is a left side perspective view of a patient interface on thepatient in use according to an embodiment of the present technology;

FIG. 62 is a front perspective view of a patient interface on thepatient in use according to an embodiment of the present technology;

FIG. 63 is a left side perspective view of a patient interface on thepatient in use according to an embodiment of the present technology;

FIG. 64 is a front perspective view of a patient interface on thepatient in use according to an embodiment of the present technology;

FIG. 65 is a perspective view of a patient interface with a bellowsaccording to an embodiment of the present technology;

FIG. 66 is a perspective view of a patient interface with a bellowsaccording to an embodiment of the present technology;

FIG. 67 is a left side perspective view of a patient interface withheadgear on the patient in use according to an embodiment of the presenttechnology;

FIG. 68 is a perspective view of a bellows according to an embodiment ofthe present technology;

FIG. 69 is a graph illustrating various dimensions of the bellows ofFIG. 68;

FIG. 70 is a perspective view of a patient interface with a ball jointand socket connector according to an embodiment of the presenttechnology;

FIG. 71 is a perspective view of a ball joint and connector according toan embodiment of the present technology;

FIG. 72 is a perspective view of a socket connector according to anembodiment of the present technology;

FIG. 73 is a perspective view of a ball joint and elbow with a ventaccording to an embodiment of the present technology;

FIG. 74 is a cross-sectional view of a ball joint and elbow with ventaccording to an embodiment of the present technology;

FIG. 75 is a perspective view of a ball joint and elbow with removablevent insert according to an embodiment of the present technology;

FIG. 76 is a perspective view of a mesh vent according to an embodimentof the present technology;

FIG. 77 is a view of a ball joint and elbow with vents according to anembodiment of the present technology;

FIG. 78 is a perspective view of a socket connector with vent groovesaccording to an embodiment of the present technology;

FIG. 79 is a left side perspective view of a patient interface withheadgear on the patient in use according to an embodiment of the presenttechnology;

FIG. 80 is a perspective view of a hybrid elbow and ball joint accordingto an embodiment of the present technology;

FIG. 81 is a cross-sectional view of the hybrid elbow and ball joint ofFIG. 80 according to an embodiment of the present technology;

FIG. 82 is a perspective side view of a patient interface with thehybrid elbow and ball joint of FIG. 80 on the patient in use accordingto an embodiment of the present technology;

FIG. 83 is a perspective side view of a patient interface with thehybrid elbow and ball joint of FIG. 80 on the patient in use accordingto an embodiment of the present technology;

FIG. 84 is a perspective side view of a patient interface with a thinmembrane and elbow assembly on the patient in use according to anembodiment of the present technology;

FIG. 85 is a perspective view of an angled elbow ball joint assemblyaccording to an embodiment of the present technology;

FIG. 86 is a left side perspective view of a patient interface withheadgear on the patient in use according to an embodiment of the presenttechnology;

FIG. 87 is a perspective view of a patient interface with headgear onthe patient in use according to an embodiment of the present technology;

FIG. 88 is a left side perspective view of a patient interface withheadgear on the patient in use according to an embodiment of the presenttechnology;

FIG. 89 is a rear perspective view of headgear on the patient in useaccording to an embodiment of the present technology;

FIG. 90 is a perspective view of a patient interface with headgear onthe patient in use according to an embodiment of the present technology;

FIG. 91 is a perspective view of a patient interface with headgear onthe patient in use according to an embodiment of the present technology;

FIG. 92 is a rear perspective view of a patient interface with headgearaccording to an embodiment of the present technology;

FIG. 92-1 is a front perspective view of a patient interface withheadgear according to an embodiment of the present technology;

FIG. 93 is a left side perspective view of a patient interface withheadgear on the patient in use according to an embodiment of the presenttechnology;

FIG. 94 is a perspective view of a patient interface with headgear onthe patient in use according to an embodiment of the present technology;

FIG. 95 is a perspective view of a ball and socket assembly incorporatedwith a ball joint portion, vent and swivel ring according to anembodiment of the present technology;

FIG. 96 is a perspective view of a swivel ring and ball joint accordingto an embodiment of the present technology;

FIG. 97 is a front perspective view of a ball and socket assemblyincorporated with a ball joint portion, vent and swivel ring accordingto an embodiment of the present technology;

FIG. 98 is a perspective view of a ball and socket assembly incorporatedwith a ball joint portion, vent and swivel ring according to anembodiment of the present technology;

FIG. 99 is a side perspective view of a ball and socket assemblyincorporated with a ball joint portion and swivel ring according to anembodiment of the present technology;

FIG. 100 is a side perspective view of a ball and socket assemblyincorporated with a ball joint portion and swivel ring according to anembodiment of the present technology;

FIG. 101 is a cross-sectional side view of a ball and socket assemblyincorporated with a ball joint portion, vent and swivel ring jointaccording to an embodiment of the present technology;

FIG. 102 is a perspective view of a patient interface with a sideconnected tube on the patient in use according to an embodiment of thepresent technology;

FIG. 103 is a front perspective view of a patient interface with a sideconnected tube on the patient in use according to an embodiment of thepresent technology;

FIG. 104 is a front perspective view of a patient interface with a sideconnected tube on the patient in use according to an embodiment of thepresent technology;

FIG. 105 is a front perspective view of a patient interface with a twoside connected tubes according to an embodiment of the presenttechnology;

FIG. 106 is a front perspective view of a patient interface with a frameand headgear according to an embodiment of the present technology;

FIG. 107 is a front perspective view of a patient interface with a frameand headgear on the patient in use according to an embodiment of thepresent technology;

FIG. 108 is a perspective view of a patient interface with a headgearcradle according to an embodiment of the present technology;

FIG. 109 is a perspective view of a patient interface with a headgearcradle according to an embodiment of the present technology;

FIG. 110 is a perspective view of headgear with hook and loop materialand a finger loop according to an embodiment of the present technology;

FIG. 111 is a perspective view of a flexible tube and ball having curvedvent grooves according to an embodiment of the present technology;

FIG. 112 is a perspective view of a flexible tube and ball having ventholes according to an embodiment of the present technology;

FIGS. 113-1 and 113-2 are perspective views of an elbow and ball havingvent grooves and a removable barrier according to an embodiment of thepresent technology;

FIG. 114 is a perspective view of a patient interface with a headgearconnecting cradle and connecting elbow according to an embodiment of thepresent technology;

FIG. 115 is a perspective view of an elbow with vent grooves and aswivel connector according to an embodiment of the present technology;

FIG. 116 is a perspective view of an elbow with vent grooves and aswivel connector according to an embodiment of the present technology;

FIG. 117 is a front perspective view of a sealing portion of a patientinterface according to an embodiment of the present technology;

FIGS. 118-1, 118-2 and 118-3 are perspective views of a sealing portionof a patient interface according to an embodiment of the presenttechnology;

FIG. 119 is a top view of a sealing portion of a patient interfaceaccording to an embodiment of the present technology;

FIG. 120 is a perspective view of a sealing portion of a patientinterface according to an embodiment of the present technology;

FIG. 121 is a front view of a sealing portion of a patient interfaceaccording to an embodiment of the present technology;

FIGS. 122-1, 122-2 and 122-3 are cross-sectional views of a sealingportion of a patient interface according to an embodiment of the presenttechnology;

FIG. 123 is a cross-sectional view of a sealing portion of a patientinterface according to an embodiment of the present technology;

FIG. 124 is a top view of a sealing portion of a patient interfaceaccording to an embodiment of the present technology; and

FIG. 125 is a top view of a sealing portion of a patient interfaceaccording to an embodiment of the present technology.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The following description is provided in relation to several embodimentswhich may share common characteristics and features. It is to beunderstood that one or more features of any one embodiment may becombinable with one or more features of the other embodiments. Inaddition, any single feature or combination of features in any of theembodiments may constitute additional embodiments.

In this specification, the word “comprising” is to be understood in its“open” sense, that is, in the sense of “including”, and thus not limitedto its “closed” sense, that is the sense of “consisting only of”. Acorresponding meaning is to be attributed to the corresponding words“comprise”, “comprised” and “comprises” where they appear.

The term “air” will be taken to include breathable gases, for exampleair with supplemental oxygen. It is also acknowledged that the PAPdevices or blowers described herein may be designed to pump fluids otherthan air.

1. PAP System

As shown in FIG. 1, a PAP system 10 generally includes a PAP device 15,an air delivery conduit 20 (also referred to as an air delivery tube ortubing), and a patient interface 100. In use, the PAP device 15generates a supply of pressurized air that is delivered to the patientvia the air delivery conduit 20 that includes one end coupled to theoutlet of the PAP device 15 and an opposite end coupled to the patientinterface 100. The patient interface 100 comfortably engages thepatient's face and provides a seal.

2. Patient Interface

Patient interface 100 may include a mask 200 and a headgear 300structured to maintain the mask in position on the patient's face inuse, as shown in FIG. 1. As illustrated, mask 200 may include a sealingportion 210, a frame 220, an elbow 230 (e.g., with swivel) adapted to beconnected to the air delivery tube 20, headgear attachments 240 (e.g.,slots or clips on the frame and/or forehead support adapted to engageheadgear straps), forehead support 250 and forehead adjustment 260.

In prior art patient interfaces such as ResMed's Mirage Quattro™ (asshown in FIG. 1), the mask is bulky and obtrusive on the face of thepatient. The substantially rigid frame 220 combined with the headgear300 encompasses a large portion of the patient's face. Such aconfiguration can psychologically discourage patients from treatment andthus negatively impact their compliance.

Another prior art patient interface is ResMed's Mirage Swift™, a nasalpillows or puff mask that seals in or around the nares of the patient.Such a configuration can cause discomfort due to the contact of thenasal pillows in or around the nares. Additionally, the “air jetting”affect can cause discomfort—this is due to laminar flow being directedup into the nares at higher velocities, thereby causing more pressure onsmall areas within the nasal passage and drying out the mucosalmembrane.

A patient interface disclosed in one or more embodiments of thefollowing description overcomes this by being less obtrusive and morecomfortable. The proposed patient interface does not seal in the naresso overcomes this discomfort. Also, the proposed patient interface has asingle opening or aperture that directs breathable gas into the patientairways, unlike a nasal pillows patient interface˜The single opening cancause more turbulence in the airflow, thereby reducing the “air jetting”affect.

3. Mask

FIGS. 1-1 to 1-18 illustrate a mask 200 including a sealing portion 210,a suspension system 215, and frame 220 according to an embodiment of thepresent technology. The mask 200 may be either a full face mask or anasal only mask. The mask 200 may also be a mouth only mask. Whilst apreferred mask is in an under the nose configuration, aspects of thepresent technology may be incorporated into other forms of mask, such asone surrounding a nose, or both a nose and a mouth.

3.1 Sealing Portion

Sealing portion 210 interfaces with the patient in use, allowingdelivery of breathable gas to the patient. In the illustratedembodiment, sealing portion 210 may form a seal with the nares of thepatient in use. For example, sealing portion 210 may interface and thusseal with the external portion of each of the alar or nostril flares,the upper lip and/or base of the nares, and the tip of the nose. Sealingportion 210 may be made from materials including but not limited to:silicone, thermoplastic elastomer, gel, foam, or any other suitablyconformable material. The material may have a durometer of about 1 to 15Shore A. Preferably, the material may have a durometer of about 3 to 10Shore A. Preferably, the material may have a durometer of about 5 to 12Shore A. Most preferably, the material may have a durometer of about 5Shore A. Thus, the preferred sealing portion provides a noninvasivearrangement that does not extend into the patient's nostrils in use. Thepreferred sealing portion 210 does not inflate, and thus does notrequire inflation pressure to form a seal. Preferably, the seal is notpressure assisted, although it could be modified for such. In one form,the sealing portion could use a gusset (e.g., having a projected areagreater than the area of the sealing portion) to help provide a seal asdisclosed in U.S. Pat. No. 7,523,754 or WO 01/97893 A1, which areincorporated herein by reference in their entirety.

In an embodiment, the sealing portion may include a wall thickness ofabout 0.1-15 mm. Preferably, the sealing portion may have a wallthickness of about 2 to 10 mm. Preferably, the sealing portion may havea wall thickness of about 7 to 12 mm. Preferably, the sealing portionmay have a wall thickness of about 1-5 mm. Most preferably, the sealingportion may have a wall thickness of about 1-3 mm. Most preferably, thesealing portion may have a wall thickness of about 1.5 mm. The wallthickness may vary in different regions of the sealing portion, e.g.,thickness of about 0.5 mm in thinner regions and ranging up to about2-10 mm in thicker regions. Alternatively, the sealing portion mayinclude a constant wall thickness, e.g., about 1.2 mm. The walls may beconstructed of various layers of material, each layer of material havinga different hardness and/or thickness (e.g., two layers each being 1.2mm thick but having different durometer silicones).

3.1.1 Shape

In the illustrated embodiment, sealing portion 210 (also referred to asa nasal cradle) may have a generally cradle, cup or U shape such thatwhen positioned under the nose of the patient, it is conformed orgenerally shaped to the alar angle of the patient (e.g., see FIG. 1-1;see also FIGS. 19 to 21 of International Patent ApplicationPCT/AU2004/000207 published as WO 2004/073 778 and the relateddescription).

The generally smooth curvature or undulating shape of sealing portion210 may be comfortable as it can flex to accommodate a variety of noseshapes and sizes. The general shape of sealing portion 210 may alsoinfer comfort and unobtrusiveness to the patient, thereby increasingcompliance.

Alternatively, sealing portion 210 may be generally flat yet be able toflex into the desired alar angle of the patient. This may be achieved byproviding sealing portion 210 with portions of reduced thickness toencourage bending and/or constructing sealing portion 210 from aflexible material or incorporating portions of flexible material.

3.1.2 Aperture

As best shown in FIGS. 1-2 to 1-7, sealing portion 210 may have anaperture 211 that allows the passage of breathable gas from the airdelivery conduit 20 to the patient. Aperture 211 may be generallycircular, rectangular, or any other desired shape (e.g., trapezoidal oroval shaped as shown in FIGS. 1-4, 1-5 and 48). In an embodiment,aperture 211 may be shaped so as to indicate the alignment ororientation of the sealing portion 210 with the patient's nose in use,e.g., trapezoidal or triangular shapes.

The aperture 211 of the sealing portion may be larger when compared tothat of a nasal pillows or prongs mask. This means that the velocity ofthe air may be lower when exiting aperture 211 compared to a nasalprongs or pillows mask. The lower velocity of air exiting the aperture211 makes it easier for the patient to exhale against the incoming airand also reduces irritation due to high velocity air flow in and aroundthe nose.

As shown in the embodiment of FIG. 48-1, the aperture 455 may havedimensions di (width) to accommodate the width of the nares on a rangeof patients with varying anthropometry and d2 (height) to accommodatenose tip height or distance from the top lip on a range of patients withvarying anthropometry. Preferably, dimension d1 may be about 10-60 mm.Preferably, dimension d1 may be about 15-40 mm. Most preferably,dimension d1 may be about 21 mm. Most preferably, dimension d1 may beabout 38 mm. Most preferably, dimension d1 may be about 58 mm.Preferably, dimension d2 may be about 1-20 mm. Most preferably dimensiond2 may be about 5-15 mm. Most preferably, dimension d2 may be about 1mm. Any other values of d1 and d2 may be used to provide a sufficientflow of gas without unduly high impedance and to fit noses of differentsizes. The radius of curvature at corner portion 457 may be 5 mm,although different radius of curvature may be used.

3.1.3 Engagement Portions

In the illustrated embodiment, sealing portion 210 may include a nosetip engagement portion 212 and an upper lip engagement portion 213. Asshown in FIGS. 1-2 to 1-4 and 1-8, nose tip engagement portion 212 isgenerally flat or planar along its length so as to provide asufficiently long sealing surface to accommodate various sized noses.The upper lip engagement portion 213 is generally curved along itslength so as to minimize contact with the patient's upper lip in use.FIG. 20-1 shows a top view of another embodiment and indicates sectionsshown in FIGS. 20-2 to 20-7. In an embodiment and as shown in FIG. 20-5,the radius of curvature R4 of the external or non-patient contactingside of the nose tip engagement portion 212 is larger than the radius ofcurvature R2 of the external or nonpatient contacting side of the upperlip engagement portion 213. In an embodiment, the radius of curvature R3of the internal or patient contacting side of the nose tip engagementportion 212 is larger than the radius of curvature R1 of the internal orpatient contacting side of the upper lip engagement portion 213. Theradius of curvature of the non-patient contacting side (e.g., R2, R4)may be different (e.g., larger or smaller) than the radius of curvatureof the patient contacting side (e.g., RI, R3). The radius of curvatureof RI, R2, R3 and R4 may be 1-5 mm, e.g. 2 mm, 3 mm, 4 mm. In anexample, R1 may be about 3-3.75 mm, R2 may be about 2 mm, R3 may beabout 3.25-4.5 mm, and R4 may be about 3.25-4.25 mm. As shown on FIG.20-2, the radius of curvature R10 and R11 may be about 8-13 mm, e.g. 9mm, 11.5 mm. In an example, RIO may be about 9.5-11.5 mm and R11 may beabout 9-10.5 mm.

3.1.4 Nostril Engagement Flaps

In the illustrated embodiment, sealing portion 210 may include nostrilengagement flaps 214 structured to align next to or against the nostrilsof the patient. In use, flaps 214 seal with the nares (e.g., eitherdirectly at the entrance to the nares or along the nostrils of thepatient) and flex or bias inwards towards the nose of the patient tostabilize or anchor the seal and enable the sealing portion 210 to fit avariety of nose sizes and shapes.

As demonstrated in FIG. 1-6, nostril engagement flaps 214 may be angledin a generally V-shaped orientation, indicated by angle a (measured fromthe center of aperture 211 and plotting the general linear path alongeach nostril engagement flap 214).

In an embodiment, angle a is in the range of about 0-180°, e.g., about90-180°, about 90-120°, about 120-180°, about 0-90°, about 0-45°, about45-90°, about 90°, about 75°-95°. Angle a demonstrates the angle of theengagement flaps when not in use or in a relaxed form. Angle a mayincrease when in use, that is, when the patient places the mask on theirnose and their nose exerts a force on the mask, and may thus cause theengagement flaps to flex outwards to an in use position. This mayinclude angles of about 750-200°. The radius of curvature as indicatedby the general area bound by a may be approximately 5-8 mm.

The nostril engagement flaps may include alternative configurations toenhance the seal. For example, as shown in FIG. 6-1, the nostrilengagement flaps 214 may be more narrow (e.g., decrease the angle a) sothat the flaps “pinch” the nose, i.e., nose flexes flaps outwardly inuse. As shown in FIG. 6-2, the flaps 214 may include hook-shaped endportions 214(1) structured to “hook” onto and seal over the patient'snares in use.

3.1.5 Flared Sealing Portion

As shown in FIGS. 1-2 to 1-8, the nose tip engagement portion 212, theupper lip engagement portion 213, and the nostril engagement flaps 214are all structured to curve or extend outwardly from an annularsupporting wall or base 219. That is, the nose tip engagement portion212, the upper lip engagement portion 213, and the nostril engagementflaps 214 are hung or cantilevered from the supporting wall such thatthey extend or curve outwardly from the supporting wall defining the airpath to outer edges of the sealing portion 210 in a continuous,uninterrupted and smooth manner.

3.1.6 Sealing Portion with Malleable Wire

FIGS. 4-1 to 4-7 show a sealing portion 210 provided with a malleablewire 270. As illustrated, the malleable wire 270 is provided to theunderside or non-face contacting portion of the sealing portion andextends about the perimeter of the sealing portion (e.g., spacedinwardly from the edge of the sealing portion to avoid any contact withthe patient's face in use). However, the malleable wire may be providedto one or more selected portions of the sealing portion (e.g., onlyalong the flaps). The malleable wire allows the patient to deform thesealing portion 210 to their specific nose shape (i.e., self-adjust thegeometry of the sealing portion) and maintain such deformed sealingportion shape during use. For example, FIG. 4-8 shows the sealingportion 210 deformed into a general V-shape, and FIG. 4-9 shows thesealing portion 210 deformed into a general flat or planar shape.

In this embodiment, the sealing portion 210 with malleable wire 270 isprovided to a base 271 adapted to attach to a frame. However, suchsealing portion may be provided to a suspension system or directly tothe frame as described below.

The malleable wire may be attached or otherwise provided to the sealingportion in any suitable manner, e.g., co-molded with sealing portion,retrofit, etc.

The sealing portion may be deformable in other suitable manners, e.g.,similar effect may be achieved by constructing the sealing portion of athermo-formable plastic material.

3.1.7 Gel Beading

As shown in FIGS. 5-1 and 5-2, gel beading 272 (e.g., tear-drop shaped)may be provided around the perimeter of the sealing portion 210 or oneor more portions of the sealing portion (e.g., along the nostrilengagement flaps) to support the sealing portion, provide compliance,and/or provide tactility in use. The gel beading 272 may be positionedalong the edge of the sealing portion (FIG. 5-1), along a portion of theedge, and/or within the edge (FIG. 5-2).

3.1.8 Fingers or Ridges

In an embodiment, fingers or ridges may be provided along theface-contacting surface of the sealing portion to enhance the seal andprevent leak in use. FIG. 7-2 illustrates an embodiment of fingers 273and FIG. 7-3 illustrates an embodiment of ridges 274. As shown in FIG.7-1, the fingers 273/ridges 274 may be provided in concentric ringsaround the sealing portion 210. However, the fingers/ridges may bearranged in other suitable manners, e.g., provided in one or moreselected regions of the sealing portion. In each embodiment, thefingers/ridges extend outwardly (e.g., height of about 0.5 mm) from theface-contacting surface of the sealing portion, and are structured todeform and conform to the various contours of the patient's face andnose in use. Such fingers/ridges may especially improve sealing inawkward positions, e.g., along the joint of the nose to the upper lip.Such fingers/ridges may also improve tactility or maintaining locationas the fingers/ridges may create a friction/stabilizing interface withthe patient's skin in use.

3.1.9 Stiffening Ribs

In an embodiment, stiffening ribs 275 (e.g., thickened portionsintegrally formed with the sealing portion) may be provided to one ormore portions of the sealing portion 210 (e.g., nostril engagement flaps214) to support the sealing portion in use. For example, as shown inFIG. 9-1, the stiffening ribs 275 may be provided in one or moreconcentric rings around the sealing portion to add strength around theentire perimeter and support the outer edges of the sealing portion 210from collapsing away from the patient's nose in use. As shown in FIG.9-2, stiffening ribs 275 may extend radially from the aperture 211(e.g., with one or more “branches” of ribs) to add support and reduceflexing in selected regions of the sealing portion, e.g., regions mostsusceptible to leak or deformation. In another embodiment, thestiffening ribs or thickened portions may be provided at discrete pointsof the sealing portion, e.g., points most susceptible to leak ordeformation. Stiffening ribs 275 may be thicker than the sealing portion210. Alternatively, stiffening ribs may be made from a differenthardness material than the sealing portion 210, e.g., a durometer ofsilicone higher than that of the sealing portion 210.

3.1.10 Gel Sealing Portion

FIG. 19 illustrates an embodiment of a sealing portion 210 constructedof gel, i.e., gel-filled bladder or membrane (e.g., wall thickness ofabout 0.3-5 mm, e.g., 0.7 mm). As illustrated, the membrane or bladder276 is filled with one or more layers of gel, and a cap 277 (e.g.,constructed of polycarbonate, silicone, polypropylene, nylon) isprovided to close and seal the opening into the bladder. In addition,the cap 277 helps to locate and maintain the gel-filled bladder to theframe 220. The gel sealing portion enhances comfort and compliance inuse.

3.1.11 Color Changing Material

In an embodiment, the sealing portion may be constructed of a materialadapted to change color, e.g., heat sensitive. For example, the sealingportion may be constructed of a color changing silicone that is heatsensitive, e.g., starts off blue (or any first color) at roomtemperature and turns white/clear (or any second color different fromthe first color) with added heat, e.g.; body temperature.

This color changing material may be used by the patient to size theirsealing portion. For example, the patient may be provided with a sealingportion for the largest size nose, and when the patient fits the sealingportion to their nose they will be able to see exactly how much excessmaterial is on the sealing portion, e.g., contact with patient's facewill heat material and change from first to second color. The patientcould then trim off the excess material to customize the mask to theirnose.

Also, the color changing material may be used for leak indication, e.g.,leaking air will be colder than body temperature so the color changingmaterial will maintain its first or original color where any leak pathexists.

The color changing material may have other applications, e.g., for thesealing portion and/or other portions of the patient interface or PAPsystem.

For example, the color changing material may be used for sterilization.If the cleaning substance to be used (e.g., water) is most effective atcleaning the mask at a certain temperature, the silicone could changecolor at this certain temperature to indicate the required sterilizationconditions have been met, e.g., the mask could turn from colored towhite/clear at 100 degrees Celsius if the best method of sterilizing themask is to boil it in hot water. Alternatively, if cleaning the maskwith alcohol is preferable, the reaction of latent heat with the appliedalcohol could cause the silicone to change color.

The color changing material may be used as an end of life indicator. Ifthe color changing silicone will only change colour a certain number oftimes before breaking down, this could be used to indicate that it'stime for a new mask.

The color changing material may be used for enhanced invisibility. Forexample, the silicone changing color to a clear silicone makes the maskbecomes less obtrusive.

The color changing material may be used as a locator. For example, thecolor of the silicone may be useful to locate parts that have beendropped or lost.

The color changing material may be used for mask asymmetry. For example,if the patient has an asymmetric nose, this could be a useful indicatorof alignment. It could suggest that the patient needs to position themask off-center to accommodate their asymmetric nose. The silicone willchange color where their nose is currently contacting the mask, and theycould adjust the position of the mask in use to ensure both nostrils areable to receive the flow of breathable gas from the mask.

The color changing material may be used on the PAP device, humidifier,and/or tubing (e.g., heated tube) to indicate that the temperature ofthe PAP device, humidifier, and/or tubing is at its limit or desiredtemperature.

In another embodiment, the sealing portion may be constructed of a colorchanging material that is pressure sensitive. In such embodiment, thepatient would be able to identify pressure points and then update themask accordingly.

An exemplary material may be Chromazone® Free Flowing Powder availablefrom Thermographic Measurements Ltd, Devon, UK.

Another exemplary material may be Thermochromatic and Liquid Crystalproducts available from B&H Colour Change Ltd, London, UK.

Another exemplary material may be Thermochromatic Inks available fromSiltech Ltd, Nottingham, UK.

3.1.12 Sizing Indicator

FIGS. 27-1 and 27-2 illustrate the sealing portion 210 withthermo-chromic sizing indicators. FIG. 27-1 shows the sealing portion210 before use with the sealing portion 210 all being color region 358.FIG. 27-2 shows an exemplary sealing portion 210 after use, where theregion touched by the patient has changed color, as shown by colorregion 360. The color change indicates the portions of the sealingportion 210 that have been contacted by the patient, and may enable thepatient to remove excess material after use (i.e., color region 360 inFIG. 27-2). The color changing portions could also be used by peoplefitting the sealing portion to the patient, whereby the change in colorwould indicate the ideal selection from among pre-made sealing portionsof various sizes.

3.1.13 Sizing Options

The sealing portion 210 may be arranged such that a single size cradlemay be produced that is able to be trimmed down or cut back into smallersizes. For example, as shown in FIG. 28, sizing of the sealing portionfor different sized patients may relate to the size of the orifice, suchthat orifice opening 362, orifice opening 364 or orifice opening 366 maybe used depending on the nose size of the patient, i.e., orifice opening366 for larger noses and orifice opening 362 for smaller noses. Theextra membrane material of membrane 348 may also be trimmed off by thepatient or a clinician. Perforations or cutting lines may beincorporated into the sealing portion 210 to indicate sizing ranges.

3.1.14 Protrusions

FIGS. 24-1 through 24-4 show a sealing portion 210 (also referred to asa nasal cradle) provided with nozzles or protrusions 320. The nozzles320 are positioned on the sealing portion 210 so as to be located in ornear the patient's nares and position the sealing portion under thepatient's nose 324 when in use. The nozzles 320 position the sealingportion 320 to enable an effective seal and provide adequate therapy tothe patient.

The nozzles 320 are provided with orifices 322 which are used to expelgas into the patient's nose 324. The nozzles 320 may not necessarilyseal with the patient's nares, instead the sealing portion 210 may sealwith the underside of the patient's nose, e.g., in a manner as describedabove. In the illustrated embodiment, the sealing portion 210 isprovided with a septum locator 326, where the patient's septum can belocated between the nozzles 320. The septum locator 326 may include acushioning material to provide comfort to the patient at this sensitiveregion of the nose. Alternative alignment protrusions or mechanisms maybe used to position the sealing portion in relation to the patient.

The nozzles 320 are configured to have a curved or concave outer surface321 that gradually increases in width from a top of the nozzles 320 to abottom of the nozzles 320 to provide a comfortable fit to differentsized noses and nares. As illustrated in FIG. 24-2, a patient with arelatively small nose 324 and nares may utilize the curved surface ofthe nozzles 320 in a way that the patient's nose extends part of the waydown the curved outer surface 321 to provide a comfortable seal. Asillustrated in FIG. 24-3, a patient with a relatively larger nose 324and nares may utilize the curved surface of the nozzles 320 in a waythat the patient's nose extends further down the curved outer surface321 to also provide a comfortable seal. At the same time, the sealingportion 210 may resistively flex to accommodate noses of different size,e.g., width.

3.1.12 Sealing Portion Comfort

FIGS. 25-1 through 25-4 show a sealing portion 210 including elementsstructure to provide comfort to the patient. For example, the sealingportion 210 may be provided with a soft, conforming cushion to enhancecomfort and thus compliance with therapy. The cushion may be constructedof a low durometer material, such as a material having a hardness ofless than 40 Shore A (or Type A). For example, the material may have ahardness of about 5-60 Shore A. Preferably, the material may have ahardness of less than 20 Shore A. Most preferably, the material may havea hardness of less than 10 Shore A.

In FIG. 25-1, a cushion 330 or pocket of soft material is positionedunder a sealing membrane 328. The membrane 328 may be constructed ofsilicone or other suitable material. The cushion 330 may be a moldedthermoplastic elastomer (TPE), a gel filled bladder, foam, or anotherconformable material or a combination of these. As illustrated, themembrane 328 includes an end portion that hooks or wraps over an outeredge of the cushion 330, such that the membrane 328 positions andretains the cushion 330 underneath the membrane 328. Locking bumps 332on a stem 334 of the sealing portion 210 may also be provided tomaintain the cushion 330 in position by preventing it from slippingdownward, i.e., locking bumps 332 provide interference to preventmovement of the cushion in the downwards direction.

The sealing portion 210 includes an orifice 336 through which breathablegas may be delivered to the patient. The membrane 328 interfaces withthe patient, and preferably prevents the cushion 330 from interfacingwith the patient, so that there are fewer constraints in material choiceof the cushion 330 due to patient safety.

FIG. 25-2 shows a similar arrangement to FIG. 25-1, but further includesa lower membrane 340 to support the cushion, i.e., an upper membrane 338and a lower membrane 340 are provided to support the cushion 330 inposition. As the patient positions the sealing portion 210 in use, thepatient will impart a patient force (as indicated by the arrow) on thesealing portion 210 and the cushion 330. In order for the cushion 330 toprovide sufficient reaction force (as indicated by the arrow) at anappropriate displacement, the lower membrane 340 supports the cushion330 in position to enable a seal with the patient and to provide comfortto the patient.

In FIG. 25-3, the sealing portion includes an upper cushion 342 providedover a lower cushion 344. In this embodiment, the sealing portion may ormay not include a sealing membrane as described above. The upper cushion342 may have one hardness and the lower cushion 344 may have anotherhardness, e.g., the upper cushion 342 may have a lower hardness than thelower cushion 344. In one example, the upper cushion 342 may have ahardness of about 5-20 Shore A (for example, about 7-15 Shore A,preferably about 7 Shore A) and the lower cushion 344 may have ahardness of about 20-80 Shore A (for example about 40-70 Shore A,preferably about 40 Shore A). However, other suitable hardnesses arepossible. The upper cushion 342 and the lower cushion 344 may be madefrom silicone, TPE, gel, foam, nylon, or a combination thereof, forexample. The lower cushion 344 may support the sealing portion 210 in aposition to be comfortable and able to seal with the patient in use. Anorifice 336 is provided through the upper and lower cushions to allowthe delivery of gas to the patient.

In FIG. 25-4, the sealing portion 210 may have a horseshoe shape 346(when viewed from the top) to cushion the nose tip portion 352 andnostril engagement flaps. This arrangement allows for molding of abladder as the cushion, since the line of draw of the molding tool (asindicated by the arrows) is straight and therefore easier to mold. Thebladder may be filled with gel, foam, TPE or any other suitablematerial. A membrane 348 may be provided to the cushion 346 andpositioned to contact the patient's upper lip in use. The membrane 348may be stretchable and/or flexible to accommodate various upper lipconfigurations. The membrane may also seal with less force on thepatient's face, and therefore be more comfortable at the upper lipposition.

In the embodiment illustrated in FIGS. 47-1 to 50, the sealing portion450 may be formed from a material and with a softness to provide patientcomfort, and to readily conform to the patient's face. For example, thesealing portion 450 may be a liquid silicone rubber material or anotherelastomeric material, e.g. TPE. The sealing portion may have a durometerof about 5-40 Shore A (preferably about 5-15 Shore A, most preferablyabout 5 Shore A) to provide comfort to the patient.

3.1.15 Membrane Flexing

In prior art cradles such as shown in FIGS. 29 and 30 in cross section,the membrane 368 is rolled in or curves inwards from the support wall370. Such an arrangement permits the patient's nose to travel into thecushion, and the membrane rolls or moves downwards to create a seal. Thesupporting walls 370 ensure that the membrane 368 is supported and hasenough room to roll or bend inwards. Such rolling may cause occlusion ofthe patient's nares, as the excess material may cover the patient'sairway.

In contrast, in embodiments of the present technology such asillustrated in FIG. 31, the membrane 348 is structured to flex outwardsor away from a center of the patient's nose in use. Alternatively thisconfiguration may be described as a trumpet or bell shape. Thesupporting wall 372 maintains the membrane 348 in its non-use positionand prevents the membrane 348 from flexing outwards beyond its intendedlimit. Since the excess material of the membrane 348 is flexingoutwards, it reduces the chance of material occluding the patient'snostrils. The excess material of the membrane 348 reduces the chances ofocclusion by removing or reducing pinch forces created by a collapsibleouter wall.

3.1.16 Membrane Support

The headgear may be attached to the membrane so as to support the outerwalls of the membrane in an upwards position, i.e., to prevent themembrane from flexing outwards into a flat position which may occludethe patient's nares or break the seal of the mask with the patient. Asillustrated in the rear view of FIG. 32-1, headgear straps 378 mayattach to the sealing portion at headgear attachment points 376. Asillustrated, the headgear attachment points 376 are at a position closeto orifice 374, so that the straps 378 may support the length of thesealing portion 210 and support the membrane 348 in an upwards positionin use. The membrane 348 therefore cannot excessively flex outwards,preventing occlusion of a patient's nares or breaking the seal of themask with the patient. The headgear straps 378 may flex and moveunderneath the sealing portion 210 at portions where the headgear straps378 are not attached via the headgear attachment, to enable greater fitrange due to the headgear being able to rest in multiple positions underthe membrane.

As illustrated in FIG. 32-2, the headgear 378 may alternatively beattached via headgear attachment points 376 at a portion farther awayfrom orifice 374, and closer to an edge of a membrane. This allowsgreater flexibility of the membrane to accommodate various shapes ofnoses (e.g., pointy noses versus flat noses).

FIG. 33-1 illustrates a supporting member 381 (e.g., a substantiallyrigid member) positioned under, within or as a part of the sealingportion 210 (the supporting member 381 is shown by the dotted line). Thesupporting member 381 is structured to force the membrane of the sealingportion 210 into contact with regions of the patient's face that aredifficult to seal in. For example, the corner of the nose and thenostril flare may be difficult to seal in as patient's have widelyvarying geometries in these regions. The supporting member 381 may bemore rigid or stiff than the membrane, thereby anchoring the sealingportion at the top lip region, corner of the nose regions 382 and thenostril flare regions 384, also ensuring that the membrane is held insealing engagement with the patient in these regions. As the tip of thenose is quite sensitive, there may be no supporting member positioned atthe nose tip region 352. The supporting member 381 may at leastpartially extend into the top lip region 350.

The supporting member 381 may be co-molded with the sealing portion 210,and may include a malleable wire or other rigid element. The supportingmember 381 may include integrally molded thickened regions to providesupport.

FIG. 33-2 illustrates an alternative supporting member 381 that does notinclude the nostril flare regions so as to allow the membrane 348 toflex in these regions. The support member 381 further extends to thenose tip region 352 to anchor the sealing portion in position with thepatient's nares. The supporting member 381 may also at least partiallyextend into the top lip region 350 and the corner of the nose regions382.

The supporting member may be co-molded or separately attached to themembrane. The support member may be made from a material with greaterhardness than the membrane 384. For example, the membrane may be aboutIO Shore A and the support member may be about 40 Shore A. However,other suitable hardnesses are possible.

As illustrated in FIGS. 34-1 and 34-2, regions of the sealing portionmay include material that is able to support the membrane 348 as well asprovide comfort to sensitive regions of the face. For example,stabilizing portions 386 may be providing at the corners of the nose andtip of the nose. The stabilizing portions should be stiff enough tomaintain the shape of the sealing portion and support the membrane 348attached or adjacent to it, while providing sufficient flexibility to becomfortable when in use. The stabilizing regions 386 may be constructedof gel, foam, TPE, silicone or any other suitable material.

3.1.17 Flexible Membrane Portions

FIG. 35-1 illustrates an alternative arrangement to FIGS. 34-1 and 34-2where the flexible or cushioning region is in the upper lip region 350.As shown in FIGS. 35-2 and 35-3, this flexible or cushioning region hasa lower durometer or lower hardness than other regions of the sealingportion, such as the nose tip region 352. In addition, the rest of thesealing portion has two layers—a lower durometer or hardness top layerL1 (i.e. layer contacting the patient's face) and a higher durometer orhardness bottom layer L2. The lower durometer material may have a highertack or stickiness than the bottom, harder layer and may thereforeprovide a friction fit with the patient's face.

3.1.18 Membrane Support

The membrane 348 may be supported by struts or tabs 390 (FIG. 36)positioned underneath the outer flaps (nostril engagement flaps) 388 ofthe sealing portion 210. The struts 390 may be attached to or positionedwith headgear connectors 376. The struts 390 prevent the outer flaps 388of the sealing portion 210 from collapsing away from the patient's face,enabling a more effective seal by maintaining the sealed position of thesealing portion 210 on the patient's face.

3.1.20 Diffuse Venting

As illustrated in FIGS. 37-1 and 37-2, the sealing portion 210 may besecured in position on the patient's head with one or more headgearstraps 390. The sealing portion 210 may also be connected to a tube 20for the delivery of breathable gas to the patient. The tube 20 mayconnect to the sealing portion 210 by a vent ring 392. As shown in FIG.37-2, the vent ring 392 includes a tube connector 398 adapted to attachthe tube 20 at one end, with a step or flange 396 to prevent the tube 20from being positioned on one or more gas washout vents 394. The ventring 392 includes a sealing portion connector 395 adapted to attach tothe sealing portion at its other end. The connector 395 provides the oneor more gas washout vents 394, which align with vent holes or tracksalong the end of the sealing portion, allowing exhaled gases to passfrom the sealing portion 210, through the gas washout vents and out toatmosphere. The gas washout vents or pathways advantageously direct airaway from the patient's face. The gas washout vents or pathways alsodisperse air around the perimeter of the vent ring 392, therebydiffusing the exhaled gases and thus preventing jetting.

3.1.21 Support of Stem

FIG. 39 illustrates a sealing portion 210 having a stem 404 for allowingbreathable gas to flow through the mask to the patient. The stem 404,which is attached to tube connection 406, may include one or more ribs402 or other supporting mechanisms to support the stem 404 and preventit from possibly collapsing and occluding the flow of gas in use. Theribs may be thickened regions or separately attachable or embeddedstruts to maintain the stem 404 in an open position. Ribs 402 may alsosupport the sealing portion 210 such that it may maintain an openposition thereby preventing occlusion of the orifice deliveringbreathable gas to the patient.

3.1.22 Supported Sealing Portion

The sealing portion 210 may be supported by a supporting portion. Thesealing portion may be totally separated from the supporting portion bya gap, or one or more portions of the sealing portion may be in contactwith the supporting portion, while other portions of the sealing portionmay be separated from the supporting portion by one or more gaps. Whensuch gaps are utilized, the corresponding portions of the sealingportion 210 may be able to stretch to fit the patient's face.

3.1.22.1 Separated Sealing Portion

FIG. 40 illustrates a sealing portion 210 that is separated fromsupporting portion 409 by a space or gap 408(1), 408(2), allowing thesealing portion 210 to flex downwards until it reaches the supportingportion 409. The supporting portion 409 prevents the sealing portion 210from losing its shape or collapsing and thus assist in maintaining aseal to the patient. The patient contacting portion 407 preferably has alower hardness than the supporting portion 409, and may be thinner thanthe supporting portion 409. The patient contact portion 407 and thesupporting portion 409 may be formed by multiple shot molding, gluing,or any other suitable method.

The top lip portion 350 of the sealing portion 210 may have a gap 408(1)between the patient contacting portion 407 and the supporting portion409 to allow for varying anthropometrics of patient upper lips. Thisalso allows flexibility of the patient contacting portion 407 near theseptum of a patient, which is a highly sensitive region. The nose tipregion 352 of the sealing portion 210 may also have a gap 408(2) betweenthe patient contacting portion 407 and the supporting portion 409 toallow for varying anthropometrics of patient nose tips. The flexibilityalso enables the patient contacting layer 407 to flex around the nosetip and thereby enhance the sealability of the sealing portion 210.

3.1.22.2 Partially Separated Sealing Portion

FIG. 47-1 shows a view of a sealing portion 450 that is supported orpositioned by supporting portion 453. The sealing portion 450 isseparated from the supporting portion 453 by a front gap in an area of anose tip engagement portion 452 between front anchor points 469, and thesealing portion 450 is connected to the supporting portion on sides ofthe sealing portion 450 outside the front anchor points 469.

The nose tip engagement portion 452 is flexible and can extend downwardwhen contacted by a patient's nose, but will be limited in how far itcan extend if it reaches the supporting portion 453. The nose tipengagement portion is extended in length from the aperture 455 to fitnose tips of different size, so that the nose tip of different patientsmay engage the nose tip engagement portion at different locations. Stem454 supports the supporting portion 453 and the sealing portion 450.Stem 454 is also adapted to receive the air delivery tube to supplypressurized breathable gas to the patient.

The sealing portion 450, the stem 454, and the supporting portion 453may be a liquid silicone rubber material or another material, e.g., TPE,gel or foam. The sealing portion 450 may be formed from a materialhaving different properties than the material forming the supportingportion 453 and the stem 454. The stem 454 and the supporting portion453 may be formed together such as in a mold, and the sealing portion450 may be formed separately and then joined together with thesupporting portion 453, e.g. such as by gluing. Alternatively, the stem454 and the supporting portion 453 may be formed together such as in amold, and then the sealing portion 450 may be bonded to the supportingportion 453 and the stem 454 in the mold.

The sealing portion 450 may have different properties than thesupporting portion 453 and the stem 454. For example, the sealingportion 450 may be formed from different (or the same) materials, have adifferent geometry, have a different hardness, than the supportingportion 453 and the stem 454.

The supporting portion 453 and the stem 454 have a hardness that isgreater than the hardness of the sealing portion 450 (which as describedabove may have a hardness of about durometer 5 Shore A), because thesupporting portion 453 and the stem 454 both support the sealing portion450, and provide a reactive force to stabilize the sealing portion 450in position on the patient's face. For example, the supporting portion453 and the stem 454 have a hardness of about durometer 20-80 Shore A.Preferably, the supporting portion 453 and the stem 454 have a hardnessof about durometer 30-65 Shore A. Most preferably, the supportingportion 453 and the stem 454 have a hardness of about 40 Shore A.

The hardness of the sealing portion 450, the supporting portion 453, andthe stem 454 may vary from the hardness levels described, but if so thena thickness of material may need to change to ensure a seal is providedwith the patient. For example, the nose tip engagement portion 452 ofthe sealing portion 450 may have a thickness of 1.2 mm with a hardnessof about durometer 5-20 Shore A (preferably about 5-10 Shore A, mostpreferably about 5 Shore A), but if a harder material is used for thesealing portion 450, then the nose tip engagement portion 452 shouldhave a thickness reduced to, for example, 0.3 mm, so that the samestiffness or reactive force is applied to the patient's face to providean effective seal.

FIG. 47-2 illustrates another view of the sealing portion 450. Thesealing portion 450 is separated from the supporting portion 453 by arear gap in an area of an upper lip engagement portion 462 between rearanchor points 475, and the sealing portion 450 is connected to thesupporting portion 453 on sides of the sealing portion 450 outside therear anchor points 475. The upper lip engagement portion 462 is flexibleand can extend downward when contacted by a patient's upper lip, butwill be limited in how far it can extend if it reaches the supportingportion 453.

FIGS. 49 (and 48-2) illustrates a front view of the sealing portion 450.The nose tip engagement portion 452 is formed as a hanging, flexiblemembrane. The sides of the sealing portion 450 are connected to orbonded to the supporting portion 453, while there is a front gap betweena central portion of the sealing portion 450 and the supporting portion453 between front anchor points 469. By utilizing this hanging, flexiblemembrane, the nose tip engagement portion 452 provides a flexiblesurface that remains in tensile contact with the nose during patientinterface movement, and better accommodates varying nose geometries.Different sized noses are provided with a comfortable and effective sealby utilizing a wide nose tip engagement portion 452, which allows thenose tip to be positioned at various locations between the aperture 455and a front edge of the nose tip engagement portion 452. The nose tipengagement portion 452 may stretch downwards towards the supportingportion depending on the size of the patient's nose.

The sealing portion 450 includes two thickened corner regions 467positioned on each side of the upper lip engagement portion 462. Thethickened corner regions 467 are adapted to seal with the patients facein use at regions of the patient's nose adjacent the nasal labialcreases. The two thickened corner regions 467 protrude outward toprovide an effective seal in this area. The two thickened corner regions467 may each have a radius of curvature of between about 2.4 mm andabout 6 mm. A radius of curvature of the upper lip engagement portionmay be about 5 mm.

A width d5 of the sealing portion 450 may be about 48 mm to fit noses upto about 45 mm in width. A larger width d5 such as 60 mm could be usedto fit noses up to 60 mm in width. A distance d6 between the nose tipengagement portion 452 and the supporting portion 453 may be about 5-20mm, preferably about 5-15 mm and most preferably about 10 mm. Thisdistance d6 has provided effective sealing of the patient interface 451with patients having nasal alar angles of up to about 135°, but may alsofit patients have nasal alar angles of up to about 200°. Distance d7, awidth of the nose tip engagement portion (and a distance (width) of theportion of the sealing portion 450 not bonded to the supporting portion453) may be about 38 mm, but for larger noses could be another valuesuch as about 48 mm, or up to about 60 mm.

A radius of curvature of the nose tip engagement portion 452 may beabout 30-45 mm, preferably about 30-40 mm and most preferably about 35mm, but to fit flatter noses, could be about 35 to 50 mm, preferablyabout 40-50 mm, and most preferably about 40 mm. At protruding edge 476in FIG. 48, an at least 1 mm bond contact radius may be used to aidtooling, where the protruding edge 476 may be clamped in a tool whilethe sealing portion is molded. A distance (height) d3 of the nose tipengagement portion is about 10 to 30 mm, preferably about 12-18 mm andmost preferably about 17 mm. A distance d4 of the nose length region isabout 20-40 mm, preferably about 25-35 mm and most preferably about 27mm, which covers nose lengths of about 12 mm to about 25 mm. Thedistance d4 could be reduced to about 17 mm for wide/shallow noses (over40 mm wide and less than 15 mm long).

FIG. 48-2 illustrates a schematic top view of the sealing portion 450.The sealing portion 450 includes an aperture 455, a front stretchportion 564, a rear stretch portion 562, side push or compressionportions 566 and side wrap or cantilever portions 568. The front stretchportion 564 and the rear stretch portion 562 are flexible portions ofthe sealing portion that can stretch or flex, when they come intocontact with the nose tip and upper lip of a patient. In these regions,sealing portion 450 is a thin membrane that is in tension and thus hugsor closely follows the geometry of the nose tip and top lip of thepatient. Preferably the respective front and rear stretch portions areheld at their ends, and unsupported in their middle. The flexibilityminimizes the force for a given displacement on the top lip and nose tipas these areas can be sensitive.

The side wrap or cantilever portions 568 are adapted to provide asubstantially horizontal or lateral force that is substantially normalto the plane of the flares of the patient's nose. As the flares of thepatient's nose fill with pressurized air, the flares are urged outwardsdue to the air pressure. The side wrap or cantilever portions 458provide a reactive force to this outwards force of the flares, ensuringa good seal in this region. Reinforcement or greater stiffness of theside wrap or cantilever portions 568 (when compared to the stretchportions 562, 564) may be required to ensure the reactive force issufficient to maintain the seal and avoid blow out or broken seal.Reinforcement may be provided by additional thickness of the sealingportion 450 in these side wrap portions, such as by utilizing a higherstiffness material, or additional structure such as a headgearattachment or ribs underlying the side wrap or cantilever portions 568.

The side push or compression portions 566 are adapted to anchor orsupport the sealing portion 450 in position. In use, the portions 566may be largely in compression. The force provided from the side pushportions 566 may be normal to the plane of the patient's face, in asubstantially horizontal direction. Since this region of the sealinginterface of the patient's face is the least sensitive, tension fromheadgear is substantially transmitted to the side push portions 566.Preferably, this is the stiffest region of the sealing portion 450. Theside push portions 566 may have a greater thickness than the frontstretch portion 562 or the rear stretch portion 564.

The sealing portion 450 has varying stiffness in different portions,i.e. front stretch portion versus rear stretch portion versus side pushportions versus side wrap portions. A stiffness of these portions isvaried by varying the materials, the hardness of the materials, thethickness of the materials, or by using supporting portions.

FIG. 50 illustrates a rear view of the patient interface 451. Thesealing portion 450 is connected to the supporting portion 453 on bothsides of the patient interface 451, and includes an upper lip engagementportion 462 that engages with a patient's upper lip in use. The upperlip engagement portion 462 is formed as a hanging, flexible membrane,with a rear gap between the upper lip engagement portion 462 of thesealing portion 450 and the supporting portion 453. The rear gap ispositioned between rear anchor points 475 that anchor the sealingportion 450 to the supporting portion 453. The flexible, hangingmembrane provides a flexible surface that remains in tensile contactwith the upper lip of the patient during patient interface movement, andcan stretch to accommodate varying facial geometries by allowingmovement of the upper lip engagement portion 462.

A thickness d8 of the thickened corner regions 467 of the sealingportion 450 could be about 1 to 5 mm, preferably about 2 to 4 mm, mostpreferably about 3.5 mm with a relatively low durometer Shore A hardnessfor comfort. The thickness d8 could be increased up to about 5 to 10 mm,preferably about 5 to 8 mm, most preferably about 5 mm depending on thethickness of the underlying supporting portion 453, and could bedecreased to a same thickness as the upper lip engagement portion 462,about 0.25 to 3 mm, preferably less than 2 mm, most preferably about 1.2mm.

The distance d9 between the unbonded region of the sealing portion 450at the upper lip engagement portion 462 and the supporting layer 453 maybe about 1 to 15 mm, preferably about 5 to 10 mm, most preferably about7 mm when not in use, and may vary between 0 mm and 15 mm, preferably upto 7 mm in use based on contact seal force to the philtrum of thepatient. The distance d10 between the top edge of the sealing portion450 and the supporting portion 453 may be about 10 to 30 mm, preferablyabout 15 to 20 mm, most preferably about 18 mm. The width of the upperlip engagement portion 462 (and a distance (width) d11 of the unbondedportion of the sealing portion 450) may be about 10 to 30 mm, preferablyabout 15 to 25 mm, most preferably about 20 mm, but this could be variedbetween about 14 mm and about 22 mm depending on nose width. A radius ofcurvature at the center of the upper lip engagement portion 462 may beabout 5 to 20 mm, preferably about 10 to 15 mm, most preferably about12.5 mm when not in use, but will lessen when in use and with inwardsflex of the patient interface 451.

The sealing portion 450 is thus connected to the supporting portion 453on both sides, but is separated by gaps from the supporting portion 453between the front and rear anchor points 469, 475. These gaps allow thesealing portion 450 to flex in use at the nose tip and upper lip regionsof the patient to provide a good fit and comfort to the patient.

FIG. 51-1 illustrates a cross-sectional side view of the patientinterface 451. A front unbonded region 460 of the sealing portion 450may have a radius of curvature of about 8 to 15 mm, preferably about 10to 13 mm, most preferably about 12.5 mm. A rear corner portion 464 ofthe sealing portion 450 may have a radius of curvature of about 1 to 7mm, preferably about 3 to 6 mm, most preferably about 4 mm. A rearunbonded region 463 of the sealing portion 450 may have a radius ofcurvature of about 2 to 8 mm, preferably about 3 to 6 mm, mostpreferably about 5 mm, but this value can vary to almost flat at theouter edge.

The sealing portion 450 may include an outer sealing margin 534 abovethe dotted line to seal with the patient's face, and a transition region536 between the opening 455 and the outer sealing margin that graduallyincreases in size from the opening to the outer sealing margin 534. Theopening 455 defines an interior surface in communication with thebreathable gas, and the outer sealing margin 534 is formed as acontinuous extension of the interior surface. Outer edges of the sealingportion 450 are oriented away from the opening 455 and/or a direction offlow of the breathable gas. The outer sealing margin 534 issubstantially convex as seen from its top view.

FIG. 51-2 illustrates a cross-sectional side view of the patientinterface 451. This embodiment includes an intermediate portion 450.1disposed between the sealing portion 450 and the supporting portion 450.The intermediate portion 450.1 may be formed as a hanging membrane. Theintermediate portion 450.1 may be molded together with the sealingportion 450, may be molded together with the supporting portion 453, ormay be molded separately from the sealing portion 450 and the supportingportion 453. The intermediate portion 450.1 may provide support to thesealing portion 450. The entire intermediate portion 450.1 may beseparated from the sealing portion 450 by a gap, such as shown in FIG.51-2, or portions of the intermediate portion 450.1 may be in contactwith the sealing portion 450 while other portions of the intermediateportion 450.1 may be separated from the sealing portion 450 by a gap.

FIG. 52-1 illustrates a support membrane 465, which may include thesupporting portion 453 and the stem 454. The supporting portion 453 andthe stem 454 may be formed as a single unitary element. The supportmembrane 465 may have a general wall section 466, a front thickenedportion 468, and a rear thickened portion 470. A front thickened portion468 and a rear thickened portion 470 are formed on each side of thesupporting portion 453. The front thickened portion 468 and the rearthickened portion 470 provide varying degrees of support to the sealingportion 450 when assembled. Support membrane 465 may be constructed of asilicone with a hardness of about 20 to 90 Shore A, preferably about 20to 60 Shore A, and most preferably about 40 Shore A. The supportmembrane 465 could also be made from polycarbonate, polypropylene,nylon, thermoplastic elastomer (TPE), Hytrel™, etc.

The front thickened portion 468 is positioned adjacent to an area of thesealing portion that contacts with sides of the patient's nose in use asseen in FIG. 47-2, and transfers headgear load into a pinch force on thesides of a patient's nose to provide an effective seal. The frontthickened portion 468 may have a thickness that increases from a top toa bottom, and have a height d12 of about 5 to 20 mm, preferably about 7to 14 mm, most preferably about 11 mm.

The rear thickened portion 470 may include a lower portion 471 having afirst thickness and an upper portion 473 having a second thicknessgreater than the first thickness. A height d 13 of the upper portion 473may be about 7 to 20 mm, preferably about 8 to 12 mm, most preferablyabout 9.5 mm, although it could be reduced to about 4 mm to reduceloading. The rear thickened portion 470 may have a curved portion 472,which may have a radius of curvature of about 0.5 to 3 mm, preferablyabout 2 mm, although it could be increased to about 4 mm to increasestiffness against the upper lip of the patient. The rear thickenedportion 470 may include a cored out portion 477 to reduce a bulk of thesilicone and to reduce a curing time.

The rear thickened portions 470 are positioned directly below thethickened corner regions 467 of the sealing portion 450, as may be seenin FIG. 47-3. The rear thickened portions 470 transfer a load from theheadgear connectors to the thickened corner regions 467 and to the lowercorners of the patient's nose to aid in providing an effective seal, andwhen the headgear is tensioned, the transfer of load to the lowercorners of the patient's nose is increased. The bending force from theheadgear connectors 456 is transferred in use by the rear thickenedportions 470 to the thickened corner regions 467 of the sealing portion450 to apply a sealing force as an anchor force to regions of thepatient's nose adjacent the nasal labial creases. The transfer of forcefrom the headgear connectors 456 to the rear thickened portions 470 mayoccur by due to the stiffened headgear connector arms, which when bent,cause the bending force, and/or by actual contact of the headgearconnectors 456 with the rear thickened portions 470.

A side upper lip portion 474 may also be thickened as compared togeneral wall section 466, and have a width d 14 that varies from about3.5 mm to 1.2 mm, to vary the amount of resistance force against theupper lip of the patient.

FIG. 52-2 illustrates a cross-sectional view of the support membrane 465and the sealing portion 450. The cross-section illustrates how thesupporting portion 453 supports and is in contact with the sealingportion 450 on the sides of the sealing portion.

FIG. 52-3 illustrates another cross-sectional view of the of the supportmembrane 465 and the sealing portion 450. The cross-section illustratesthe difference in thickness between the lower portion 471 and upperportion 473 of the rear thickened portion 470, and illustrates the coredout portion 477.

FIG. 52-4 illustrates a cross-sectional view of the support membrane 465and the sealing portion 450 as it interfaces with and seals with apatient. The nose tip engagement portion 452 engages with and seals withthe patient's nose tip. When the nose tip engagement portion 452 andupper lip engagement portion 462 are fitted to the patient's nose tipand upper lip, the nose tip engagement portion 452 and the upper lipengagement portion 462 are stretched towards the supporting portion 453.

FIG. 52-5 illustrates a side view of the support membrane 465 and thesealing portion 450 as it interfaces with and seals with a patient. Thesides of the sealing portion 450 and the supporting portion 453 pinchwith and seal with the sides of the patient's nose. The thickened cornerregions 467 seal with the patient at regions of the patient's noseadjacent the nasal labial creases. The rear thickened portion 470 ispositioned adjacent to and below the thickened corner region 467 toprovide additional sealing force.

FIG. 52-6 illustrates another cross-sectional view of the supportmembrane 465 and the sealing portion 450 as it interfaces with and sealswith a patient. The sides of the sealing portion 450 seal with the sidesof the patient's nose, and are supported in this area by the supportingportion 453, the front thickened portion 468 and the rear thickenedportion 470.

FIG. 52-7 illustrates a front view of the support membrane 465 andsealing portion 450 as it interfaces with the patient's face. The nosetip engagement portion 452 engages with and seals with the patient'snose, and stretches towards the supporting portion 453. The front anchorpoints anchor the sealing portion 450 to the supporting portion 453 onboth sides of the nose tip engagement portion 452. The sides of thesealing portion 450 engage with and seal with the sides of the patient'snose.

FIG. 53 illustrates a front view of the support membrane 465. Thedistance d15 between the front thickened portions 468 may be about 25 to45 mm, preferably about 35 to 42 mm, and most preferably may be about 40mm. The distance d15 may be varied to change stiffness of contactbetween the headgear and side walls of the membrane to increase a pinchload on sides of the patient's nose. Distance d16 between the rearthickened portions 470 may be about 35 to 55 mm, preferably about 40 to50 mm, most preferably about 46 mm. Varying d16 varies the point atwhich the headgear contacts the rear thickened portion 470 to increaseor reduce load.

FIG. 54 illustrates a front view of the support membrane 465 withheadgear connectors 456. The headgear connectors 456 may be formed as asingle unitary element molded with the support membrane 465, or could beformed separately and attached to the support membrane 465. The headgearconnectors 456 may include headgear tabs 458 for connecting theheadgear. The distance d21 from a bottom of the headgear connectors 456to a top of the support membrane may be about 10 to 25 mm, preferablyabout 12 to 20 mm, most preferably about I 7 mm. The distance d20between the outer ends of the headgear connectors may be about 60 to 100mm, preferably about 70 to 90 mm, most preferably about 80 mm. Theheadgear connectors 456 may be angled upwards at an angle a1, which maybe about 2 to 15°, preferably about 5° to 8°, most preferably about6.5°. The higher the angle a1, the lower the moment of pinch forceapplied by the patient interface.

As shown in FIG. 55, the headgear connectors 456 are placed towards thebase of the sealing portion 450 in order to create a moment force on theside walls. As the headgear force is applied by tightening the headgearstraps, a load is placed on the headgear connectors 456 and the tabs458, which promotes an inward force on the sides of the sealing portion450, to provide a seal force to the sides of the patient's nose. Whenthe headgear straps are tightened, the pinch load moment force appliedto the sealing portion 450 may cause the inward displacement of thesealing portion 450 to reduce a width of the sealing portion by almostone half from an initial width without the headgear straps in place. Thebending force from the headgear connectors 456 is transferred in use bythe supporting portion 453 to the sealing portion 450 as a pinch forceto sides of the patient's nose.

The stiffness of the side walls of the support membrane 465, thestiffness of the headgear connectors 456, and the connection point ofthe headgear connectors 456 all affect the amount of pinch forcetransferred to the sealing portion 450. The headgear connectors 456 mayhave a thickness of about 2.5 mm to 4.0 mm, with the side walls of thesupport membrane 465 having a thickness of about 1.2 mm to 5.0 mm, withboth using silicone having a hardness of about durometer 40 Shore A todurometer 65 Shore A. The headgear connectors 456 and the side walls ofthe support membrane 465 do not have to be a constant thickness, but thethickness can vary along their length and width or they may havelocalized thickened regions to control stiffness in specific regions.Also, there may be additional silicone at the point where the headgearconnectors 456 connect to the support membrane 465. Headgear connectorsmay alternatively be constructed of stiffer material than silicone suchas nylon, polycarbonate, polypropylene or other suitable material. Thismay aid connection of the headgear to the headgear connectors.

FIG. 55 illustrates a top view of the support membrane 465 with headgearconnectors 456. The supporting portion 453 may include recessed regions478 formed in an upper surface of the supporting portion 453, to allowthe stiffness of the supporting portion 453 to be reduced by filling therecess with a low hardness filling material, having a lower hardnessthan the supporting portion. The recess may be about 8 mm by 9 mminwards from the upper most surface of supporting portion 453, althoughother size recesses could be used. A reduced stiffness of the supportingportion 453 allows a lesser pinching force to be applied to thepatient's nose (when compared to a supporting portion with a higherstiffness), which can provide a more comfortable seal. Distance d17between a center point of the orifice 479 and a center of the headgearconnectors 456 may be adjusted to bias the load on the patient interfacefrom front to back, and d17 may be about 2.7 mm, although values between0 mm and 4.0 mm may be used. The headgear sweep angle a2 may be varied,and increasing a2 biases a load towards the back (upper lip area) of thepatient interface. The headgear sweep angle a.2 may be about 6.6°,although values between 0° and 10° may be used.

FIG. 56-1 illustrates a side view of the support membrane 465 withheadgear connectors 456. Distance d18 between the top of the headgeartab 458 and the rear corner load points formed by rear thickened portion470 may be about 1-5 mm, preferably about 1-3 mm, most preferably about2 mm, to allow the headgear tabs 458 a certain amount of movement beforethey touch the patient interface. This helps to stop the sealing portionfrom closing while it is first being fitted by the patient. The anglea.3 may be 90°, which could be varied by +/−5° If the headgearconnectors 456 are not molded to the support membrane 465, this anglemay vary by +/−10°, and varying a3 biases the angle that the patientinterface sits under the patient's nose (naso-labial angle).

FIGS. 56-2 and 56-3 illustrate cross-sectional side views of the supportmembranes 465 illustrated in FIG. 56-1 and FIG. 52, respectively. Thestem 454 may be adapted to connect to a ring for connection to an airtube. The ring could have a socket type fitting for a ball joint and/orinvolve venting. The diameter at the base of the stem 454 has to besufficient to allow an air path with flow limitations for flow generatorcompatibility, and could have a diameter of 8 to 25 mm, preferably lessthan 20 mm and preferably about 1 5 mm. However, different diameterscould be used, e.g., 12 mm.

The stem 454 may include a thin walled portion 481, which may have aheight d19 of 5.5 mm, although d19 may be varied between, e.g., 2 mm to10 mm. The thin walled portion 481 allows flex of the decouple region ofthe stem 454 with drag of a tube connecting thereto. The thin walledportion may have a wall thickness of about 0.3 mm to 1.0 mm depending onflex and strength requirements. The stem 454 may contain stiffening ribsin a radial or circumferential manner, either internal or external, orother stiffening elements.

3.1.23 Seal with Patient

The sealing portion 210 provides an effective seal with a patient's nose324, as illustrated in FIGS. 44-46. The nostril flare portions 384 ofthe sealing portion 210 provide a seal with a patient's nostril flares385. The nose tip portion 352 provides a seal with the patient's nosetip 353. The upper lip portion 350 provides a seal with the patient'supper lip 351. The nostril flare portions 384, nose tip portion 352 andupper lip portion 350 all help provide an effective and comfortable sealwith the patient, and help position the orifice 336 adjacent to thepatient's nares.

3.2 Suspension System

In FIGS. 1-1 to 1-18 for example, the sealing portion 210 is attached orotherwise provided to a suspension system 215. Attachment may bepermanent (e.g., including but not limited to: single component mold(e.g. see FIGS. 1-2 to 1-8), co-molding, insert molding, gluing, or anyother suitable means). Alternatively, attachment may be with removablemeans (e.g., including but not limited to: clips, Velcro™, tongue andgroove, or any other suitable means). In an embodiment, attachment ofthe sealing portion 210 to the suspension system 215 may occur along theperimeter of aperture 211 on sealing portion 210 and aperture 216 onsuspension system 215.

Suspension system 215 may be provided to mask 200 to decouple or absorbforces from the sealing portion 210 and the remaining components ofpatient interface 100 (e.g., air delivery tube 20). Suspension system215 may be formed from a generally flexible material such as silicone,foam, gel or any other suitable material.

3.2.1 Shape

Suspension system 215 may have a generally wedge or triangular shapedcross section as shown in FIGS. 1-8 and 1-14. Such shape may help toorient the sealing portion with respect to the patient's nose in use.

The surface adjacent aperture 216 of suspension system 215 may begenerally U or V shaped as shown in FIGS. 1-12 and 1-13. Such surfacemay define an angle θ between about 90-180°, e.g., about 110-160°.Alternatively, suspension system 215 may be relatively flat.

In an embodiment, suspension system 215 may be similar to the gussetdisclosed in U.S. Patent Application Publication No. 2009/0044808published 19 Feb. 2009, which is incorporated herein by reference in itsentirety. In an embodiment, suspension system 215 may be similar to thedecoupling element disclosed in PCT Application No. PCT/AU2009/000240,filed 27 Feb. 2009, which is incorporated herein by reference in itsentirety.

3.2.2 Connection to Frame

In the illustrated embodiment of FIGS. 1-1 to 1-18, suspension system215 includes a connecting ring 217 to sealingly attach suspension system215 to a frame 220. Connecting ring 217 may interface with a channel 227provided along the frame perimeter to form an interference fit. Theinterference fit may be achieved by a tongue and groove, snap fit or anyother suitable means. In another embodiment, the connecting ring 217 maybe adapted to attach to an elbow 230 and/or an air delivery conduit 20.For example, elbow 230 may interference fit within, around or againstconnecting ring 217 so as to seal the connection of the elbow 230 or airdelivery conduit 20 with the suspension system 215.

The connecting ring 217 defines aperture 218 to allow the passage ofbreathable gas from frame 220 into suspension system 215. The aperture216 allows the passage of breathable gas from the suspension system 215to the sealing portion 210.

3.2.3 Foam or Gel Suspension System

Suspension system 215 may constructed of an alternative material tosilicone that may provide greater compliance, resilience, flexibility,comfort, and/or consumer appeal.

For example, the suspension system may be constructed of foam. Foam actsas a spring to support the sealing portion 210 and urge it towards thenares of the patient in use. The compliance of the foam also enablesadjustment of the seal position. FIGS. 3-1 to 3-6 show various views ofa foam suspension system 215 for use between the sealing portion 210 andthe frame 220. The foam may be an open or closed cell foam or a foamwith a combination of open and closed cells. The foam may be skinned orun-skinned. The foam may be 1-50 mm thick, e.g., 30 mm thick.

In an alternative embodiment, the suspension system may be constructedof gel. Gel may be conformable, compliant and comfortable. In anembodiment, multiple durometer gels may be used. FIG. 8-1 illustrates agel suspension system 215 according to an embodiment of the presenttechnology. As illustrated, the gel suspension system 215 is in the formof an encapsulated gel jacket 278 provided between the sealing portion210 (e.g., silicone) and a base 279 (e.g., plastic). In an embodiment,the gel suspension system may alter the geometry of the sealing portion,e.g., flex thinner regions of the sealing portion (e.g., nose tipengagement portion). The gel may be a silicone gel, polyurethane gel orany other suitable gel. The gel may a gel as disclosed in PCTapplication No. PCT/AU2008/001711, filed 17 Nov. 2008, which isincorporated herein by reference in its entirety.

In an embodiment, the sealing portion 210 may overhang the foam or gelsuspension system to reduce weight and enhance compliance along theedges of the sealing portion 210 to fit a wider range of patient'sfacial geometries. For example, FIGS. 8-2 and 8-3 illustrate the sealingportion 210 (e.g., silicone) overhanging a gel suspension system 215.Such overhang allows the edges of the sealing portion to “give” or“pinch” depending on orientation to enhance the seal. As illustrated,edges of the sealing portion 210 may include a tear-drop shape gelpocket to facilitate sealing in gaps and corners of the patient's facein use.

In a further embodiment, the suspension system could be constructed froma thermoplastic elastomer (TPE).

3.2.4 Sealing Portion with Flexible Tube

In an alternative embodiment, the suspension system may be in the formof a flexible tube that is provided (e.g., co-molded) or otherwiseattached to the base of the sealing portion.

As shown in FIG. 16-1, the flexible tube 280 may be corrugated to allowthe tube to move relative to the sealing portion 210 in any direction,e.g., compress, expand, bend, etc., e.g., like a drinking straw

As shown in FIG. 16-2, the flexible tube 280 is provided with flexiblespiral ribbing which allows the tube to resiliently bend relative to thesealing portion 210.

In each embodiment, the end of the tube may be coupled directly to theair delivery tube in use.

In each embodiment, the flexible tube 280 may have a constant wallsection. Alternatively, the flexible tube 280 may have a varying wallthickness to, for example, alter the stretch, elongation or flexibilitycharacteristics of the tube in specific regions.

In an embodiment, one or more vents may be provided to the tube (e.g.,molded into tube, insert molded, attached to tube as separate insert)and/or one or more vents may be provided to a swivel on the end of thetube.

As shown in FIG. 26, a concertina portion 354 and a hinge portion 356may be provided between the sealing portion 210 and the tube 20. Theconcertina portion 354 absorbs movement of the tube 20 when the tube 20rotates away from the patient's face in use. That is, when the sealingportion 210 is positioned, the tube 20 cannot flex into the patient'sface as the patient's chin or other parts of the patient's face willprevent such movement. When the tube 20 flexes away from the patient'sface in use, the hinge portion 356 will transmit the movement of thetube 20 into the concertina portion 354 and thus prevent movement of thesealing portion 210, preserving the seal with the patient. The hingeportion 356 may also prevent the concertina portion 354 from stretchingout, preventing the concertina section 354 from losing structuralintegrity and allowing the concertina section to continue absorbingmovement of the tube 20. FIG. 26 also shows the position of the nose tipportion 352 and the upper lip portion 351 of the sealing portion.

3.2.5 Gusset

In an embodiment, as shown in FIG. 17-1, the suspension system may be inthe form of a gusset or decoupling chamber 281 that is provided (e.g.,co-molded) or otherwise attached to the base of the sealing portion 210.In use, the gusset 281 may expand/compress/tilt to enhance the range ofadjustability.

The thickness of the gusset side walls may be constant, for exampleabout 0.2 to 3 mm thick, preferably 0.2 to 1 thick, most preferably 0.3mm thick. Alternatively, the gusset side walls may be varied throughout,for example some regions may be thicker than others to aid coupling ofthe air delivery tube to the gusset, or some regions of lesser thicknessthan others to promote flexibility in that region.

In this embodiment, the base of the gusset may be coupled directly tothe air delivery tube 20 in use.

In another embodiment, as shown in FIG. 17-2, headgear connectors 240may be provided to the sealing portion 210 for attaching headgear. Asillustrated, the headgear connectors may extend from a trampoline-typebase 282 which allows the sealing portion to flex, stretch, and/orbounce relative to the headgear connectors and hence the headgear toalleviate pressure in use. Such arrangement enhances adjustability alongwith the gusset. Preferably, headgear connectors 240 may be between thesealing portion 210 and the flexible base 282 to permit decoupling oftube forces from the sealing portion 210.

Furthermore, an additional trampoline-type arrangement 283 may beprovided to the base of the gusset 281 to allow additional adjustabilityof the air delivery tube to relative to the gusset.

3.2.6 Tube Decoupling Mechanism

The sealing portion 210 may be provided with a spring portion 413 (FIG.41) to absorb or take up tube drag forces. The spring portion 413 mayhave a width 416 that is less than the width 418 of the sealing portion(cradle) connection portion 399 and the swivel connection portion 414.The swivel connection portion 414 may connect to a swivel ring 415 suchas the embodiment described above. FIG. 41 also shows headgear straps390 attached to the sealing portion 210 to support the mask in positionon the patient's head.

3.2.7 Swivel Ring Diffuse Venting

The swivel ring 415 may include one or more gas washout vents 422. Thegas washout vents 422 may take provided as one or more aperture, hole,slot or scallop. FIGS. 42-1 and 42-2 illustrate a swivel ring 415 withone or more gas washout vents 422 cut out of the inner wall thatinterfaces with an elbow wall 426 (shown in dashed lines), to form oneor more vent slots or gas washout vents 422 that enable expired gases topass through and exit from the mask to atmosphere. There may be one ormore vent slots or gas washout vents 422 (3 shown), which are formedbetween the support walls 424. The elbow wall 426 interfaces with theinner wall 423 of the swivel ring 415 and also the support walls 424.The support walls 424 prevent the elbow from accidental disassembly.

FIG. 42-3 illustrates where the swivel ring 415 connects to the sealingportion 210 at cradle flange 430 and to the elbow at elbow flange 432.The swivel ring 415 is inserted into an aperture in the sealing portion210 and is retained by an interference fit with the flanges on eitherside of the sealing portion interference web 434. The sealing portioninterference web 434 may be U-shaped, although other shapes may be used.In an example, the swivel ring 415 may be structured similar to thatshown in PCT/AU2008/001557 filed Oct. 22, 2008, which is incorporatedherein by reference in its entirety.

FIG. 42-4 illustrates alternative gas washout vents 422 where there isan array of small holes provided as the gas washout vents 422 within theswivel ring 415. The gas washout vents 422 (e.g., from 5-50, or about15) may be about 0.5-1.0 mm, e.g., 0.7 mm, in diameter.

FIG. 42-5 illustrates alternative gas washout vents 422 where there is asingle vent slot provided as the gas washout vent 422 in the swivel ring415. FIG. 42-6 illustrates another alternative gas washout vents 422where there are multiple vent slots provided as gas washout vents 422 inthe swivel ring 415 (e.g., more than 2, or about 5-20).

FIG. 42-7 illustrates an array of vent holes provided as gas washoutvents 422 arranged about the swivel ring 415. As illustrated, two rowsof vent holes are provided as the gas washout vents 422, with the ventholes from each row being offset or staggered from one another. The ventholes may be positioned or arranged in other configurations.

FIG. 42-8 illustrates an exemplary cross section of the vent holesprovided as gas washout vents 422 shown in FIG. 42-7. The diameter] ofthe vent holes varies from the entrance to the exit in this embodiment,e.g., the vent holes tapers along their length. The diameter D 1 of thevent holes on the side of the swivel ring 415 facing the sealing portion210 is greater than the diameter D2 on the other side of the swivel ring415. The diameters D1 and D2 could also be the same, or the diameter D2could be greater than the diameter D1. The diameter of the vent holesmay be about 0.5-1.0 mm. Preferably, the diameter of the vent holes maybe about 0.7 mm.

In all of the above venting examples, the venting is directed downwardsand therefore away from the patient's face, and along the elbow or airdelivery tube. The vent holes 422 are also arranged on only half or aportion of the swivel ring 415 so that air may avoid being directedtowards the patient's chest in use.

3.2.8 Vent Direction

As illustrated in FIG. 43, the direction of air expelled from the vent395 may be modified by positioning the attachment of the elbow 397 tothe sealing portion 210 using a plenum 438. The plenum 438 may attachthe sealing portion 210 in an upwards position so as to engage with apatient's nose in use. The plenum 438 may attach via swivel ring 415 toelbow 397 in a location where it will avoid contacting the patient anddirect air away from the patient when in use. The plenum 397 may furtherabsorb tube drag forces by buckling or compressing when the tube dragforce is applied, rather than dislodging or moving the sealing portion210 from its sealed position.

3.3 Frame

FIGS. 1-9 to 1-14 show the suspension system 215 connected to the frame220 (without sealing portion 210 provided to the suspension system 215),and FIGS. 1-15 to 1-18 show the suspension system 215 connected to theframe 220 (with sealing portion 210 provided to the suspension system215). In the illustrated embodiment, the suspension system 215 includesconnection ring 217 adapted to be push fit into channel 227 on frame220. Alternatively, suspension system 215 may be connected to frame 220by other removable means, e.g., such as clips, hooks, zip locks or anyother suitable means. Also, suspension system 215 may be attached toframe 220 by permanent means, e.g., including but not limited to insertmolding, co-molding, gluing, etc.

Frame 220 may be generally more rigid than suspension system 215 andsealing portion 210 to support and stabilize sealing portion 210 and/orsuspension system 215. Frame 220 may be made from, including but notlimited to, silicone, TPE, polycarbonate, polypropylene, foam, gel,nylon etc.

As best shown in FIG. 1-10, frame 220 may include an aperture 226adapted to connect to an elbow 230 or to an air delivery tube 20. Frame220 may connect to elbow 230 or air delivery conduit 20 by a snap fit,tongue and groove mechanism or any other removable or non-removableconnection. Exemplary connections are disclosed in U.S. PatentPublication No. US 2009-0044808, which is incorporated herein byreference in its entirety.

3.3.1 Headgear Attachments

In the illustrated embodiments, frame 220 includes headgear attachmentsor connectors 240 to removably attach headgear 150 and/or headgearrigidizers 160 to the mask 200, as shown in FIGS. 1-1 and 1-9 to 1-18.Headgear attachments 240 may be made from, e.g., including but notlimited to: silicone, TPE, polycarbonate or any other suitable material.Headgear attachments may be molded with frame 220. Alternatively,headgear attachments may be provided to the suspension system 215 and/orsealing portion 210 as described below. Alternatively, headgearattachments may be attached to any part of the mask 200 by, e.g.,including but not limited to: gluing, push clip, snap fit, etc.

As illustrated in FIGS. 61 to 64-2 and 67, the patient interface 459 maybe secured to the patient with headgear 484. The headgear 484 may extendin use from the headgear connectors 456 between the patients eyes andears on each side of the patients head and connect at the top portion ofthe patient's head. An adjustable connector 500 may allow the adjustmentof the headgear to fit the patient. The headgear 484 may include a backof head portion 485 that wraps around the back of the patient's head.

In an embodiment, headgear attachments may include those disclosed inU.S. Patent Application Publication No. 2009/0044808 published 19 Feb.2009, which is incorporated herein by reference in its entirety.

3.3.1.1 Orientation

In the illustrated embodiment, the headgear connectors 240 extendgenerally perpendicular to the longitudinal axis of frame 220 as shownin FIG. 1-12, e.g., indicated with f3. As shown in FIG. 1-1, therigidizers 160 are rotatably coupled to respective headgear connectors(as described in U.S. Patent Application Publication No. 2009/0044808incorporated herein by reference) to allow adjustment to suit thenasolabial angle for a large range of patients. In addition, sucharrangement allows adjustment of the suspension system to move thesuspension system away from the patient's top lip.

3.3.1.2 Alternative Positioning

In an alternative embodiment, headgear connectors may be provided closerto the sealing portion to improve stability of the seal as it eliminatesor reduces the length of the moment arm. For example, FIG. 10illustrates headgear connectors 240 provided to the sealing portion 210directly.

In another embodiment, the headgear connectors may be positioned so thatthe headgear straps/rigidizers extend under the nostril engagement flaps214 in use. For example, as shown in FIG. 11, the headgear connectors240 may be provided to the suspension system 215. In use, the headgearstraps 190/rigidizers 160 are positioned under the nostril engagementflaps 214, which straps/rigidizers act as stops to prevent furtherdeformation of the flaps and/or urge the flaps upwards in use. Thestraps/rigidizers are positioned to engage specific regions of the flapand allow remaining portions of the sealing portion to bend or conformin use. As illustrated, a strut 284 may be placed under the flaps forengaging the straps/rigidizers.

In another embodiment illustrated in FIG. 47-3, a patient interface 459includes headgear connectors 456. The headgear connectors 456 mayinclude tabs 458. The tabs 458 may provide connection points forconnecting headgear. The headgear connectors 456 may be molded togetherwith the stem 454. Alternatively, headgear connectors 456 may beremovably attachable to stem 454 and/or the supporting portion 453. Forexample, headgear connectors 456 may be clipped, wrapped or otherwiseconnected to the stem 454.

Headgear connectors 456 may have a hardness of about durometer 20 to 80Shore A, preferably about 20 to 60 Shores A, and most preferably about40 Shore A. The geometry of the supporting portion 453 may be adjustedto be molded with the headgear connectors 456.

The position of the headgear tabs 458 relative to the sealing portion450 is important. If the headgear tabs 458 are too low, i.e. furtheraway from the sealing portion 450, they may not provide enoughstability. The greater the distance from the sealing portion 450 to theheadgear tabs 458, the longer the lever arm and hence a greater tendencyfor movement of the sealing portion 450. If the headgear tabs 458 aretoo close to the top of the sealing portion 450, the sealing portion 450may hinge inwards beyond what is required for seal, and increase theforce on the patient's nose. There could also cause a possibility ofocclusion of the patient nares. Accordingly, the headgear tabs 458should be 1 to 10 mm from the sealing portion. Preferably, the headgeartabs 458 should be about 2 to 5 mm from the sealing portion.

Further details of such headgear connectors and tabs are disclosed inPCT/AU2008/001557, filed Oct. 22, 2008, which is incorporated byreference herein in its entirety.

3.3.2 Sealing Portion Support

In an embodiment, as shown in FIGS. 18-1 and 18-2, the frame 220 mayinclude an exoskeleton or support arrangement 290 structured to urge thenostril engagement flaps 214 towards the nostrils in use. Asillustrated, the fingers 291 provided by the exoskeleton 290 willsupport and shape the sealing portion when engaged therewith. That is,the exoskeleton is constructed of a more rigid material than the sealingportion, so that the fingers may flex/deform, but to a less extent thanthe sealing portion so that the fingers will urge or pinch the sealingportion on the patient's nose.

In an embodiment, the base of the sealing portion may include a rollingmembrane 292 adapted to fit into the exoskeleton so as to provide someadjustability of the sealing portion to relative to the exoskeleton(e.g., compress or expand).

In an embodiment, the sealing portion and exoskeleton may be provided asa one-piece molding or may be formed separately and attached to oneanother.

4. Headgear

As best shown in FIG. 1-1, headgear 150 may include side straps 190, topstrap 1 70, back strap 180 and rigidizers 160 provided to respectiveside straps 190 (e.g., stitched onto respective side straps).

In the illustrated embodiment, the rigidizers provide end portionsadapted to engage respective headgear connectors 240 on the frame, e.g.,with a snap fit, as shown in FIG. 1-1. However, the rigidizers may becoupled to respective headgear connectors in other suitable manners,e.g., rigidizers include openings adapted to receive respective lug-likeheadgear connectors.

In an embodiment, headgear 150 may include headgear disclosed in U.S.Patent Application Publication No. 2009/0044808 published 19 Feb. 2009,which is incorporated herein by reference in its entirety.

The rigidizers may be configured to add support to selected areas of themask. For example, the rigidizers may provide cheek supports (like thosedisclosed in U.S. Patent Application Publication No. 2009/0044808)and/or the rigidizers may be configured to engage lower cheek or chinportions for supporting/locating the mask in use (see FIG. 12).

In an alternative embodiment, headgear straps may be constructed ofsilicone and rigidizers may be co-molded into respective siliconestraps.

In the illustrated embodiment, the headgear provides a two-pointconnection to the mask. However, other arrangements are possible, e.g.,three-point, or more.

4.1 One-Piece Headgear

FIGS. 13-1 and 13-2 illustrate headgear 150 constructed in one piece,e.g., cut from material as a one-piece structure. As illustrated, theheadgear 150 includes a central portion 185 and side straps 190 adaptedto engage one another, e.g., via a buckle arrangement. The centralportion 185 includes an opening 186 for receiving and supporting asealing portion 210. As shown in FIG. 13-3, the headgear may include acontoured portion 187 surrounding the opening 186 which is adapted tosupport the sealing portion in use.

In an embodiment, as shown in FIG. 13-4, the region 188 surrounding theopening 186 may be configured to provide a trampoline-type arrangementto the sealing portion 210 which allows the sealing portion to flex,stretch, and/or bounce relative to the headgear 150 to alleviatepressure in use. For example, the region surrounding the opening may bethinner than the remaining portions of the headgear.

In another embodiment, as shown in FIG. 13-5, the headgear 150 may beformed in one piece with the sealing portion 210.

In each of the above arrangements, the air delivery tube 20 may beconnected directly to the base of the sealing portion 210.

4.2 Adhesive Headgear

As shown in FIG. 15, instead of headgear, adhesive strips 285 may beprovided to respective nostril engagement flaps 214 to adhere thesealing portion 210 directly onto the patient's face. However, thestrips may be provided to a lower portion of the sealing portion, e.g.,as indicated in dashed lines in FIG. 15. Examples are disclosed in U.S.patent application Ser. No. 12/478,537, filed Jun. 4, 2009, which isincorporated herein by reference in its entirety.

4.3 Other Headgear

FIG. 86 illustrates headgear 484 that includes a strap 527 and a backstrap 529. The strap 527 includes slots 531 for attaching to headgearconnectors 456 (FIG. 47-2), and an adjustable connector 500. The strap527 could connect to the headgear connectors 456 by other connectingstructure, e.g., utilizing hook and loop type connectors.

The strap 527 is configured to extend in use between the patient's eyesand ears and connect at the top of the patient's head with theadjustable connector 500. The flexible tube 486 may be attached to thestrap 527 in the area of the adjustable connector 500 of strap 527 by atube clip or other retention means, to hold the flexible tube 486 inplace at the top of the patients head.

Back strap 529 is configured to extend in use around the back of thepatient's head to assist in maintaining the strap 527 in position. Theback straps may include a connector 500 for connecting at the back ofthe patient's head, or alternatively may be a single piece strap. Thestrap 527 and the back strap 529 may be silicone or other suitablematerial, such as elastic or TPE.

FIGS. 87-89 illustrate headgear 533 that includes two side portions 535and a rear portion 524 connected to each of the side portions 535. Theside portions 535 each contain a first slot for connecting to theheadgear connectors 456 (FIG. 47-2), and a second slot 537 forconnecting to the rear portion 524. The rear portion 524 may have an endportion 526 that threads through the second slot 537. The end portion526 may be formed with a hook-type material, for connecting to aloop-type material 528.

The side portions 535 may be formed from a silicone material, which maybe molded. The silicone material may reduce the visual bulk of the sideportions 535 by giving them a more streamlined appearance. The rearportion 524 may be formed from a softer material to provide comfort tothe patient, such as a soft polymeric material, e.g., TPE orthermoplastic urethane (TPU).

The rear portion 524 may include one or more rigidizer or stiffener tohelp maintain the shape of the headgear and also secure and position theheadgear in relation to the patient's crown and/or occiput. The one ormore rigidizer may be constructed of a rigid or semi-rigid materialstructured to add rigidity or stiffness to the headgear and anchor theheadgear in position in use. The rigidizer may be able to bend or deformalong its length but resist or prevent stretching of the headgear in thelengthwise direction of the rigidizer. The rigidizers may besubstantially inextensible. The rear portion 524 may wrap around a crownof the patients head. The rigidizer may be resilient. The rear portionmay be thermoformed and/or ultrasonically die cut, such as disclosed inPCT/AU2009/001605, filed Dec. 10, 2009. The headgear disclosed inPCT/AU2009/001605 may be utilized with the present technology disclosedin this application, and PCT/AU2009/001605 is hereby incorporated byreference in its entirety.

FIGS. 90 to 93 illustrate headgear 539 that is formed in one piece. Theheadgear 539 covers over the front of the patient interface in area 541and covers the headgear connectors 456 to give a more streamlinedappearance. Rigidizers may be included in or on the headgear 539 foradded stability.

FIG. 94 illustrates headgear 543, which is similar to headgear 539 inthat it covers over the front of the patient interface in area 541.However, headgear 543 includes cutout portions 545 that allow theheadgear tabs 532 to be visible on the outside of the headgear 543. Thisarrangement may assist in alignment of the headgear with the patientinterface.

FIG. 110 illustrates headgear 484 that may be used with any of theembodiments herein, and includes a hook and loop attachment. A loopmaterial 560 may be positioned on a first portion of the headgear 484,and a hook material 562 may be positioned on a second portion of theheadgear 484. The hook material 562 and the loop material 560 fastenwhen pressed together, but allow a user to pull them apart when acertain amount of force is exerted.

A finger loop 558 may be included on the hook material 562 to aid theuser in gripping and finding the end portion of the hook material 562. Abuckle 590 may be attached to an end of the portion of the headgear 484having the loop material 560 to aid in alignment and guide the hookmaterial 562 portion of headgear 484 into position on the loop material560. The buckle 590 and finger loop 558 may be interchanged, i.e., thebuckle 590 at the end of the hook material 562 and the finger loop onthe loop material 560 portion of the headgear 584.

5. Elbow

In FIG. 1-1, the elbow 230 (e.g., with swivel) is generally L-shaped andis adapted to connect the mask to the air delivery tube 20.

In an alternative embodiment, the elbow may be bendable or flexible toprevent or reduce tube drag in use. For example, as shown in FIGS. 14-1and 14-2, an intermediate portion of the elbow 230 may include a seriesof corrugations 286 and a living hinge 287 to allow end portions of theelbow to pivot relative to one another in use. Such corrugated elbow maybe molded in one piece (e.g., 2-shot mold, co-mold, insert mold) or maybe an assembly (e.g., 2 or 3 part assembly).

In another embodiment, as shown in FIG. 14-3, a flexible region 288 maybe incorporated into the elbow 230 to allow end portions of the elbow tomove relative to one another in use. The flexible region may beconstructed of resilient material (e.g., TPE, soft rubber) to allow theflexible region to compress and expand. Such elbow may be formed bymolding, e.g., 2-shot mold, co-mold, insert mold.

In another embodiment, a corrugated region 289 may be provided betweenend portions of the elbow 230 to allow the end portions to move relativeto one another in any direction, e.g., compress, expand, bend, etc. Suchelbow may be formed by molding, e.g., 2-shot mold, co-mold, insert mold.In another embodiment, as illustrated in FIG. 38, a generally L-shapedelbow 397 connects to a sealing portion or mask system at one end and toa tube at the other end, e.g., sealing portion connector 399 to asealing portion or mask system, and tube connector 398 to a tube. A vent395 may be positioned between the connectors. The elbow 397 isconfigured such that when the patient is wearing a mask, the elbow 397moves the tube connector 398 away from the patients face and upwards ofthe mask, so that the tube may be positioned over the patients head inuse. The vent 395 advantageously directs expired air away from thepatients face in use. Connector 398 may attach the an air delivery tubeand connector 399 may attach to a mask, such that the vent 395 isparallel to the patient and facing directly away from the patient'sairways.

6. Sealing Portion without Suspension System

In an alternative embodiment, the mask 200 may be provided without asuspension system between the sealing portion 210 and the frame 220,i.e., sealing portion attached directly to frame as shown in FIGS. 2-1to 2-6.

In such embodiment, sealing portion 210 may be removably connected toframe 220 by, e.g., including but not limited to: snap fit, tongue andgroove, clips, etc. Alternatively, sealing portion 210 may bepermanently connected to frame 220 by, e.g., including but not limitedto: co-molding, insert molding, gluing, etc. In an alternative form,sealing portion 210 may be constructed in one piece with the frame 220.

6.1 Shape

Sealing portion 210 may be generally rectangular or elliptical whenviewed from the top, as shown in FIG. 2-7B. In an alternativeembodiment, sealing portion 210 may be generally triangular ortrapezoidal when viewed from the top, as shown in FIG. 2-7 A. Theembodiment of FIG. 2-7 A is structured to reduce the amount of excessmaterial in the sealing portion 210 that may cause discomfort or be lessobtrusive. This may also be to indicate alignment to the patient, i.e.,the patient may be more likely to correctly align a triangular shapedsealing portion 210 as the nose is naturally shaped more like a triangleand thus the nose tip engagement portion 212 and upper lip engagementportion 213 are more likely to be oriented in their desired locations.

As shown in FIGS. 2-8B and 2-9B, the upper lip engagement portion 213 ofthe rectangular-shaped sealing portion is sufficiently long such thatits free end overhangs at least a portion of the frame, e.g., to preventengagement of the patient's upper lip with the frame in use. Inaddition, the upper lip engagement portion may be sufficiently long soas to accommodate a variety of nose and upper lip shapes (e.g., theembodiment shown in FIG. 2-8B may have a larger fit range of patient'sthan the embodiment shown in FIG. 2-8A). In the triangular-shapedsealing portion embodiment, as shown in FIGS. 2-8A and 2-9A, the lengthof the upper lip engagement portion 213 is shortened or abbreviated,e.g., to reduce the amount of excess material. FIG. 2-10 illustrates thetriangular-shaped sealing portion embodiment engaged with patient's facein use.

FIG. 2-11 is a rear view of a sealing portion showing a portion of theupper lip engagement portion 213 to be removed (shaded section), e.g.,with respect to the sealing portions of FIGS. 2-8B and 2-9B. Thereduction of material in the upper lip engagement portion may improvecomfort and appeal of the mask (i.e., more unobtrusive look) and mayimprove leak performance.

7. Alternative Mask to Tube Connections

FIGS. 57 to 85 and 95 to 101 illustrate various alternative mask to tubeconnections that may be utilized with the present technology.

7.1 Thin Membrane

As illustrated in FIG. 57, thin membrane 482 may be disposed between thesupporting membrane 465 and flexible tube 486. In this embodiment,headgear connectors 456 allow connection of headgear 484. As illustratedin FIG. 58, a degree of freedom of movement is provided between thesupport membrane 465 and the flexible tube 486 by thin membrane 482,which may join the flexible tube 486 to the patient interface 459 viaswivel ring 480. Thin membrane 482 may stretch, flex or otherwiseelastically deform to permit movement between the supporting membrane465 and flexible tube 486. Thin membrane 482 may have a wall thicknessthat is less than the supporting membrane 465. Thin membrane 482 mayhave a wall thickness of about 0.2 to 5 mm. Preferably, thin membrane482 may have a wall thickness of about 0.5 to 2 mm. Most preferably,thin membrane 482 may have a wall thickness of about 0.5 to 1 mm.Movement between the tube 486 and the sealing portion 450 may be limitedby the length of the membrane 482, which may be adjusted based on adesired amount of movement. Any additional movement becomes a functionof the flexible tubing.

7.2 Multi-Axis Elbow Assembly

FIGS. 59 to 64 illustrate a multi-axis elbow assembly 495 that createsadditional degrees of freedom by allowing rotation in two separateplanes, as shown by the arrows in FIG. 59, for example. The multi-axiselbow assembly 495 includes frame 491 which may be connected to thinmembrane 482 or to support membrane 465, elbow 488 connected to frame491, swivel assembly 494, swivel ring 492, and elbow 490.

The additional degrees of freedom provided by the multi-axis elbowassembly 495 have a marked impact on the functionality of the patientinterface 459. For example, the multi-axis elbow assembly 495 allows theflexible tube 486 to easily be placed on either side of the patient'shead, as illustrated in FIGS. 60 and 61, to be positioned along the noseand between the eyes of the patient as illustrated in FIG. 62, whilebeing streamlined (not bow outward), while applying a moment to thepatient interface that is almost zero. Additionally, as shown in FIGS.63 and 64, the flexible tube 486 may also be positioned in a downwardconfiguration or in an outward configuration, respectively. Themulti-axis elbow assembly 495 allows the tube 486 to be placed in manydifferent positions that may be utilized by a patient while not applyingsignificant moment to the patient interface created by tube drag toprovide an effective and comfortable seal with the patient.

7.3 Bellows Short Tube Decouple

A bellows or concertina tube decouple is illustrated in FIGS. 65-69. Aseries of bellows 502 connects to patient interface 459 at one end, andconnects to a tube 506 at the other end. The tube 506 may have a swivelconnector 504, which may be used to connect to a gas supply tube, forexample. The bellows 502 includes a bore with a plurality of supportiverings that helps prevent air path occlusion under tight bendingconditions, i.e. the bellows may have a thicker wall section than theportions of the bore without the bellows portions. Alternatively, thebellows and the bore may have a constant wall section. The length of thebellows may be selected to provide a decoupling function, to retain theseal of the patient interface 459 despite bending of the bellows 502.The bellows 502 thus provides a degree of freedom of movement betweenthe patient interface 459 and the tube 506.

The bellows 506 may be molded as a unitary structure with the supportmembrane 465, or may be a separately, removably attachable element. Thebellows 502 may be formed from a material with a hardness of aboutdurometer 20 to 80 Shore A, preferably 20 to 60 Shore A and mostpreferably about 40 Shore A to match the support membrane 465 so thatboth parts may be molded together, and where the bellows 502 is aseparate element, it may have a different hardness, such as aboutdurometer 20-40 Shore A, preferably about 20 Shore A. Preferably, when adurometer of Shore A 40, a preferred thickness is about 0.3 mm.

The bellows 502 may have an internal bore of 8 to 20 mm, preferably 10to 15 mm, most preferably 12 mm or 15 mm. A thin membrane may be usedbetween the bellows 502 and the support membrane 465 of the patientinterface 459.

The added flexibility of the bellows 502 allows the tubing 506 to beeasily positioned overhead as illustrated in FIG. 67, to the side of thehead, outward or downward with minimal force on the patient interface459. The bellows 502 has a wide separation between rings to ensureadequate bending with the tube. The bellows 502 prevents occlusion ofthe air path when the tube bends sharply.

FIG. 69 illustrates various dimensions of the bellows rings and sidewallshown in FIG. 68. Each bellows ring has a height of e.g., 2 to 6 mm,preferably 3 to 5 mm, most preferably 5 mm, including the sidewall, anda width of, e.g., about 2 to 8 mm, preferably about 3 to 6 mm, mostpreferably about 4 mm. The radius RI of the curved portion between eachbellows ring may be about 1 to 4 mm, preferably about 2 to 3 mm, mostpreferably about 2.5 mm, the separation between the rings of the bellowsis, e.g., about 2 to 8 mm, preferably about 4 to 6 mm, most preferablyabout 5 mm, and the thickness of the side wall of the bellows ring is,e.g., 0.2 to 2 mm, preferably about 0.5 to 1.5 mm, most preferably about0.3 mm. The radius of the bellows 502 measured from an inner side of thebottom of each curved portion between the bellows ring is, e.g., about 4to 12 mm, preferably about 6 to 10 mm, most preferably about 7.5 mm.These values may be varied but have been found to provide improvedimpedance and overall tube/patient interface compatibility whileproviding a very flexible bellows at about durometer 20 to 60 Shore A,preferably about 40 Shore A.

7.4 Ball and Socket

FIG. 70 illustrates a patient interface 459 that connects to a flexibletube 486 via a ball and socket connection. The ball and socketconnection includes a ball 508 and a socket connector 510. The ball 508,also illustrated in FIG. 71, may be connected to the flexible tube 486by connector 507, also illustrated in FIG. 72. The socket connector 510may be connected to the patient interface 459. The socket connector 510may be a conventional elbow ring sized to accept the ball 508. Thesocket connector 510 may also include a diffuse vent allowing exhaledair from the patient to be vented.

The ball and socket connection provides decoupling of movement of theflexible tube 486 to relieve moment created on the patient interface 459created tube drag. As the flexible tube 486 is moved about, the ball 508may move about in socket connector 510.

FIGS. 73 and 74 illustrate the ball 508 connected to an elbow 509. Theelbow 508 may connect to a flexible tube. The elbow 509 includes a bend,which may be, e.g., about 90° to 150°, preferably about 100° to 130°,most preferably about 110°, although other angles may be used. The elbow509 may include a vent 511, which may include one or more vent holes 513for venting exhaled air. The vent holes 513 may be an array of spacedapart vent holes. Preferably, the internal diameter of the bend is about7 to 15 mm. Preferably, bend may have an internal diameter of less than12 mm. Most preferably, bend may have an internal diameter of about 8mm.

Ball 508 may preferably have outside diameter in the range of about 15to 19 mm. Most preferably, ball 508 may have an outside diameter ofabout 17 mm.

Ball 508 may preferably have an internal diameter of about 7 to 15 mm.Preferably, ball 508 may have an internal diameter of less than 12 mm.Most preferably, ball 508 may have an internal diameter of about 8 mm.

As illustrated in FIG. 75, the vent may be in the form of a removableinsert 517. The removable insert 517 may be attached to the elbow 509 bystructure to lock it in place, such as lugs, tongue and groove, etc. Theinsert may be a mesh vent 515, as shown in FIG. 76.

FIG. 77 illustrates an embodiment in which the ball 508 includes aseries of vent grooves 501. The vent grooves 501 may have a length toextend to both sides of the socket connector 510 in use, so that exhaledair may exit through the vent grooves 501. Vent grooves may have alength of about 2 to 50 mm. Preferably, vent grooves 519 may extendalong the outer surface of the ball 508 to create a long vent flow path.A long vent flow path may reduce the noise of the exiting gases as thevelocity of the air may decrease. Preferably, vent grooves 519 aredistributed around ball 508 to diffuse the exiting air flow paths.Preferably, vent grooves 519 are molded on ball 508. Preferably, grooves519 have a width of about 0.2 to 3 mm. Preferably, grooves 519 have awidth of less than 1 mm. The thinner the groove, the slower the air flowand hence the quieter the vent. The grooves 519 may be generally linearor may have various other configurations. A curved or tortuous pathwayis preferred as this may increase the length of the vent flow path andhence reduce the noise of the vent. The walls of ball 508 adjacent thegrooves 519 may interface with the connector 510. Connector 510 may lieover the top of groove 519 and hence form a cover over grooves 519.

FIG. 111 illustrates an embodiment in which the ball 508 includes aseries of curved vent grooves 564. The curved vent grooves 564 may alsohave a width of about 0.2 to 3 mm. Preferably, vent grooves 564 have awidth of less than 1 mm. The ball 508 may be connected to a tube 486 orto an elbow 509 or other element.

FIG. 112 illustrates an embodiment in which the ball is a perforatedball 568, which includes a series of vent holes 570. The perforated ball568 may allow the air to flow between a connector (such as connector510) and the ball 568. The ball 508 may be connected to a tube 486 or toan elbow 509 or other element.

FIGS. 113-1 and 113-2 illustrate an embodiment with a ball 508 havingvent grooves 570, in which a flow path barrier 592 may be removablyattachable to the ball 508. The flow path barrier 592 may interface witha connector 510 to create a flow path between the barrier 592 and theconnector 510.

FIG. 78 illustrates an alternative socket connector 521. The socketconnector 521 includes vent grooves 523. The vent grooves 523 allowexhaled air to exit the patient interface. The vent grooves 523 mayextend radially outwards (as shown). Alternatively, vent grooves 523 mayextend axially. Alternatively, vent grooves 523 may extend along theinner surface of the inner wall of socket connector 521.

FIG. 79 illustrates the patient interface 459 utilizing the ball 508 andsocket connector. The ball 508 may be freely moved in the socketconnector providing a degree of freedom of movement, allowing the tub486 to be placed in various positions.

7.5 Hybrid Elbow and Ball Joint

FIGS. 80 to 83 illustrate a hybrid elbow and ball joint. Elbow assembly514 includes a swivel connector 512 and a socket connector 518. Ballassembly 516 includes a ball 522 and a swivel connector 520. The ball522 mates with the socket connector 518.

The elbow assembly 514 may utilize an angle of, e.g., 90° to 150°,preferably about 100° to 130°, most preferably about 110°. Thecombination of the elbow assembly 516 with the ball joint providesmultiple degrees of freedom of movement. For example, utilization of anelbow without the ball joint would either force the connected tubing toclose to the patient's chin in the tube down position, or too far out inthe tube up position. Utilizing the elbow assembly with the ball jointallows the tube to be place in more desirable positions.

FIG. 82 illustrates the elbow assembly 514 utilizing the ball assembly516, with the flexible tubing 486 in the downward position. The ball 516allows positioning of the flexible tube 486 away from and not in contactwith the patient's face.

FIG. 83 illustrates the elbow assembly 514 utilizing the ball assembly516, with the flexible tubing 486 in the upward position. The ball 516allows positioning of the flexible tube 486 closer to the patient'sface, to help prevent obstruction of vision.

7.6 Thin Membrane with Elbow

FIG. 84 illustrates the thin membrane 482 utilized with elbow assembly514 and a swivel connector 512. The sealing portion 450 includes anaperture that exits at an angle downward from the horizontal, making itdifficult to be able to achieve both the tube-up and tube-downpositions. The thin membrane 482 is flexible to be able to adjust theexit angle to a more horizontal position. The thin membrane 482 thusallows the flexible tube 486 to hang downward without applying excessmoment to the sealing portion 450, and also allows the flexible tube 486to be properly positioned in the upward position.

7.7 Angled Elbow Ball Joint

FIG. 85 illustrates an angled elbow and ball joint assembly 525. Theangled elbow ball joint assembly 525 includes an elbow 514, a ball 516,and a swivel connector 520 for connecting to the flexible tube 486. Theangled elbow ball joint assembly 525 may include an angle of, e.g., 100°to 160°, preferably about 100° to 130°, most preferably about 110°. Theball 516 may be connected to a socket connector such as illustrated inFIG. 70. The ball 516 provides the freedom of movement that will allowthe flexible tube 486 to be properly positioned in the upward ordownward positions.

7.8 Ball and Socket Assembly

FIGS. 95 to 101 illustrate a ball and socket assembly 561 incorporatedwith a ball joint portion and swivel ring. Swivel ring 550 may interfacewith the mask or support membrane 465. Ball 552 is placed within theswivel (see FIG. 101) to allow 360° rotation of the ball joint portion548 axial to the swivel ring 550, and to move in planes other than axialto the swivel ring 550. Alternatively, the swivel ring 550 may beomitted and the ball 552 may interface with the mask.

Connector 556 is adapted to connect to a flexible gas supply tube, sothat gas may be supplied in the air passageway 560 in the direction ofarrow 558. The air passageway may have an internal diameter of 11-15 mm,and the connector 556 may have the same internal diameter. A vent 554may be incorporated into ball joint portion 548, to vent exhaled gasfrom a patient.

The swivel ring 550 may be manufactured in a mold and set. The swivelring 550 may then be placed in a tool, where the ball joint portion 548is molded about or within the swivel ring 550. As the material of theball joint portion 548 cools down, it will shrink off of the swivel ring550. The vent 554 may be molded into the ball joint portion 548.

7.9 Side Connected Tube

FIGS. 102 to 104 illustrate a patient interface 459 with a sideconnected flexible tube 486. In all of the embodiments, the patientinterface 459 may include the sealing portion 450 and the supportmembrane 465, even if not specifically illustrated. Two apertures 538are located on each side of the patient interface 459, and allowconnection of the flexible tube 486 on either side of the patientinterface 456, extending towards the side (laterally). A plurality ofvent holes 544 may also be included, for venting gas exhaled by thepatient.

An elbow 542 may be connected to the end of the flexible tube 486, andbe adapted for connection to the aperture 538. The elbow may include aswivel connector allowing the flexible tube 486 to be swiveled todifferent positions, such as an upward position along a side of thepatient's face, as illustrated in FIG. 103, or a downward position, suchas illustrated in FIGS. 102 and 104. A plug 540 may be utilized on anaperture 538 to which the flexible tube 486 is not connected, to sealthe aperture 538.

The side connected tube presents a streamlined appearance and moves thetube 486 away from the face of the patient. The side connected tube alsodecouples tube drag forces from the sealing portion 450. Further detailsof the side connecting interface are disclosed in U.S. application Ser.No. 12/377,801 filed Feb. 29, 2008, which is incorporated herein byreference in its entirety.

7.10 Two Side Connected Tubes

FIG. 105 illustrates a patient interface 459 which utilizes two sideconnected flexible tubes 548. A frame 546 may be utilized to support thepatient interface 459. The flexible tubes 548 may have a smallerdiameter than when one flexible tube is utilized. For example, theflexible tubes 548 may have half the diameter as when one tube isutilized. This may provide more comfort to the patient, particularly ifthe patient rolls over onto one of the tubes 548.

7.11 Rigid Frame Over Patient Interface

FIGS. 105 to 107 illustrate a rigid frame 546, which may be adapted tofit over and support the patient interface 459. For example, the rigidframe may be shaped to fit over the patient interface 459. The rigidframe 546 may include headgear connectors 456 for connecting to headgear484.

The frame 546 may be formed from a rigid material to provide rigidsupport. Further details of the frame 546 are also disclosed in U.S.application Ser. No. 12/377,801, which is incorporated herein byreference in its entirety.

7.12 Headgear Cradle

FIGS. 108 and 109 illustrate a headgear cradle portion 552 adapted toconnect to patient interface 459. The headgear cradle portion 552 mayinclude an aperture 554 for connecting the headgear cradle portion 552to the patient interface 459. The headgear cradle portion 552 may haveapertures at its ends to receiver the headgear 484.

The headgear cradle portion 552 may also tactile ends 550 to enhance apatient's grip to ease in connecting and disconnecting of the headgear484. The headgear 484 may use hook and loop material to connect. Theheadgear cradle portion 552 may also include a conformable pad 556internal to the headgear cradle portion 552. The conformable pad 556supports the patient interface 459 and provides decoupling between thepatient interface 459 and the headgear cradle portion 552. Theconformable pad 556 also provides a softened feel to the patient whenusing the patient interface 459.

7.13 Elbow With Lugs

FIG. 114 illustrates an embodiment in which a patient interface 459connects to headgear 484 and an elbow 582. The patient interfaceincludes a connector 578 having apertures 580. The headgear 484 has aheadgear connector 557 shaped to interface with connector 578, byfitting over the outside of connector 578. The lugs 586 of the elbow 582fit within the apertures 580. The elbow 582 is adapted to form anairtight connection with the connector 578. The headgear 484 may haveapertures if needed near the headgear connector 557 to receive portionsof the elbow 582 near the lugs 586.

7.14 Vented Elbow Assembly

FIGS. 115 and 116 illustrate a vented elbow assembly. The vented elbowassembly includes an elbow 509, a swivel ring 550 and a connector 556.The swivel ring 550 may be connected to a patient interface 459 or asupport membrane 465, and the connector 556 may be connected to aflexible tube supplying gas.

The elbow 509 may include a series of vented grooves 558 for venting gasexhaled by the patient. The vented grooves 558 may be of differentlengths, and may be arranged parallel or perpendicular to the directionof gas flow through the elbow 509.

8. Additional Embodiments

FIGS. 23-1 to 23-7 show an additional embodiment of the presenttechnology. FIG. 23-1 shows a patient interface 3000 with an interfacingportion (also known as sealing portion) 2000 positioned above or on topof a supporting portion 1000. Supporting portion 1000 is shown in FIGS.21-1 to 21-6. Supporting portion 1000 may have a nose tip portion 212B,nostril portions 214B, and an optional upper lip portion 213B. Regionsunderneath or on the non-patient contacting side may have ridges orthickened sections to provide additional support to interfacing portion2000 when assembled, and to provide varying degrees of support to thesealing portion 210. Supporting portion 1000 may be constructed of asilicone with a hardness of about 20 to 90 Shore A, preferably about 40Shore A. The supporting portion 1000 could also be made frompolycarbonate, polypropylene, nylon, thermoplastic elastomer (TPE),Hytrel™, etc. The supporting portion 1000 may be about 1-15 mm thick,preferably 1.2 mm. As best shown in FIG. 21-4, upper lip portion 213 Bmay be cut out or removed.

FIGS. 22-1 to 22-4 show interfacing portion 2000. Interfacing portion2000 may have a nose engagement portion 212A, nostril engagementportions 214A, and an upper lip engagement portion 213A. Interfacingportion 2000 may engage with the patient in use. Interfacing portion2000 may be made from a silicone, with a hardness of about 7 durometeron the Shore A scale. Alternatively, the hardness of the interfacingportion 2000 may be about 12 durometer on the Shore A scale. Thethickness of interfacing portion 2000 may be about 1.2 mm. Theinterfacing portion 2000 may be made from other suitable materials suchas nylon, a textile, TPE, etc. The interfacing portion may have apolished surface finish for tactility and to ‘stick’ or tack on to thepatient's skin in use.

FIGS. 23-1 to 23-7 show interfacing portion 2000 attached to orpositioned on top of support portion 1000. Interfacing portion 2000 maybe co-molded, insert molded, glued or otherwise attached to supportportion 1000. Interfacing portion 2000 may be permanently attached orremovably attached.

As best show in FIGS. 23-3 and 23-6, nose engagement portion 212A may beraised or supported above nose portion 212B. This arrangement may bebeneficial for allowing patient's noses to flex into nose engagementportion 212A, thereby allowing a greater fit range. Nose portion 212Bsupports the side walls of the interfacing portion 2000. As best shownin FIG. 23-5, upper lip engagement portion 213A is suspended over thegap at upper lip portion 213B. This allows flexibility of the patientinterface 3000 at the patient's upper lip region, thereby allowing agreater range of fit.

FIG. 117 illustrates a patient interface 600. The patient interface 600includes a sealing portion 600 for sealing with the patient's face, asupporting portion 608, and a connecting portion 610 for connecting to asupply of gas, such as a flexible tube. An optional gusset 604 may alsobe included.

Headgear may be attached to the patient interface 600 creating headgearvectors in an area such as position 606. This may be accomplished bydisposing headgear connectors under the sealing portion 602 on thesupporting portion 608, for example. An optional gusset 604 may beincluded between the sealing portion 602 and the supporting portion 608.

FIGS. 118-1, 118-2 and 118-3 illustrate a patient interface 612. Thepatient interface 612 includes a sealing portion 602, a supportingportion 616, a gusset 614 between the sealing portion 602 and thesupporting portion 616, and a connecting portion 618 to a supply of gas,such as a flexible tube, and an aperture 620.

The sealing portion 602 interfaces and creates a seal with the face ofthe patient, typically with the upper lip and nose of the patient. Thesealing portion 602 may include stiffened portions, such as portions ofthe sealing portion 602 that interface with the patient at regions ofthe patient's nose adjacent the nasal labial creases. The stiffenedportions of the sealing portion 602 may be formed from anon-compressible material such as a gel or a material such as a highdurometer silicone as compared to other portions of the sealing portion602. Alternatively or in addition, structural support may be added suchas ribs or thickened portions on sides of the sealing portion or on thesupporting portion, such as in the embodiment of FIG. 52-5, and/or thegusset 614 may be filled with a stiff material to provide additionalsupport.

FIG. 118-3 illustrates a cross-sectional view that includes a gel filledpocket 622 in the corner region of the sealing portion 602, and such agel filled pocket may be located in each corner region. The gel filledpocket 622 may be utilized to provide the stiffened portions and providea more effective seal with the patient in use. A gel filling location623 may be included allowing a user or patient to add or remove gel asneeded.

FIG. 119 illustrates a top view of a sealing portion 602 of a patientinterface. The sealing portion 602 may include an orifice 602 fordelivering gas to the patient in use. The orifice 602 may have asubstantially trapezoidal shape as illustrated, or may be asubstantially triangular shape. These shapes are closer to the shape ofa patient's nose, which allows a patient to more easily put the patientinterface on in the correct orientation.

FIG. 120 illustrates a patient interface 630, which includes a sealingportion 632, a supporting portion 636, an optional gusset 638, and aconnecting portion 640. The sealing portion 632 may be a single wallsealing portion, and in this embodiment may include a second sealingwall 634 underneath the sealing portion (forming a first sealing wall)to provide additional support.

FIG. 121 illustrates a patient interface 642, which includes a sealingportion 644, a supporting portion 652, and an optional gusset 650. Inthis embodiment, the front portion 648 (nose engaging portion) of thesealing portion 644 is curved downward making the sealing interfacedeeper and more curved. This shape allows the side walls of the sealingportion to flex outwards more with flatter noses, and allows more pointynoses to rest in the curvature provided by this shape.

FIGS. 122-1 and 122-3 illustrate cross-sectional views of the patientinterface 600 or 642, with the addition of a soft, conformable supportstructure. A support structure 604 is provided below the sealing portion602. The support structure 604 may be foam or another soft, conformablematerial, while the sealing portion 602 and support portion 606 aresilicone or other similar material as described herein. The supportstructure 604 may fit into an indent formed in the side wall of thesealing portion 602 or in the supporting portion 606. The supportstructure 604 may have a varying width as illustrated, or may have aconstant width. Three support structure 604 may be in the shape of aring.

As illustrated in FIG. 122-3, the support structure 604 may provide anadditional contact on the patient's upper lip in use, and because thematerial of the support structure 604 is soft and conformable, it mayprovide additional comfort to the patient in use. Additionally, thesupport structure 604 may assist in providing a seal with the patient'supper lip. FIG. 122-2 illustrates the support structure 604 with asealing portion that curves outward at its outer edges.

The cross-section of the foam ring may vary in different regions. Forexample in a tip of nose region, the foam ring may have a smallcross-section and be readily able to flex to fit different sizes ofnose. In a side of nose region, e.g. adapted to be located adjacent acrease region of a face, the foam ring may be thicker.

The foam ring may incorporate different densities of foam and vary thelevel of support in different regions.

FIG. 123 illustrates a cross-sectional view of an inwardly curvingsealing portion 620. The ends of the sealing portion 620 have beenlengthened so as to seal against the sides (flares) of the patient'snose and provide side support 622, rather than sealing just on theunderside of the nose. This provides a more effective seal.

FIGS. 124 and 125 illustrate a top view of a patient interface 630having a sealing portion 636 that includes nasal prongs 634 disposed onan upper surface 640 of the sealing portion 636. The nasal prongs 634are adapted to form a seal with the patient's nares in use. A supportingportion 638 may be optionally included under the sealing portion.

As illustrated in FIG. 125, the sealing portion 636 may include supportportions 642 disposed adjacent to the nasal prongs 634. The supportportions may be foam or another suitable material, and are disposed inan area of the sealing portion 636 that interfaces with an upper lip andcorners of the nose of the patient in use, to provide support and securethe sealing portion 636 and the nasal prongs 634 in place.

It is believed that a patient interface in accordance with the presenttechnology is more able to accommodate different sizes and shapes offaces and noses than prior designs. It is believed that a patientinterface in accordance with the present technology may reduce the needfor inventory in different sizes. It is believed that a patientinterface in accordance with the present technology can provide improvedcomfort for patents, and improved compliance with their therapy.

While the technology has been described in connection with what arepresently considered to be the most practical and preferred embodiments,it is to be understood that the technology is not to be limited to thedisclosed embodiments, but on the contrary, is intended to cover variousmodifications and equivalent arrangements included within the spirit andscope of the technology. Also, the various embodiments described abovemay be implemented in conjunction with other embodiments, e.g., aspectsof one embodiment may be combined with aspects of another embodiment torealize yet other embodiments. Further, each independent feature orcomponent of any given assembly may constitute an additional embodiment.In addition, while the technology has particular application to patientswho suffer from OSA, it is to be appreciated that patients who sufferfrom other illnesses (e.g., congestive heart failure, diabetes, morbidobesity, stroke, bariatric surgery, etc.) can derive benefit from theabove teachings. Moreover, the above teachings have applicability withpatients and non-patients alike in non-medical applications.

1-20. (canceled)
 21. A positive airway pressure system for treatment ofsleep disordered breathing, comprising: a mask with a seal portion thatis shaped to seal with a face of a patient around nares of the patientwhen the mask is worn by the patient, the seal portion defining a firstaperture to provide pressurized air from an interior of the mask to bothnares of the patient, the seal portion comprising a hanging flexiblemembrane that surrounds the first aperture and includes: a nose tipengagement portion shaped to contact a tip of a nose of the patient whenthe mask is worn by the patient and being flexible toward a distalportion of the mask when the nose tip engagement portion contacts thenose of the patient; an upper lip engagement portion shaped to contactan upper lip region of the patient, a base of the nose of the patient,or both the upper lip region of the patient and the base of the nose ofthe patient; a first nostril engagement flap portion located between thenose tip engagement portion and the upper lip engagement portion on afirst side of the mask; and a second nostril engagement flap portionlocated between the nose tip engagement portion and the upper lipengagement portion on a second side of the mask opposite from the firstside of the mask; and headgear structured to maintain the mask inposition on the face of the patient when the mask is worn by thepatient, the headgear including: a first side headgear portionattachable to the mask at the first side of the mask so that the firstside headgear portion extends between a first eye of the patient and afirst ear of the patient on a first side of a head of the patient whenthe mask is worn by the patient; and a second side headgear portionattachable to the mask at the second side of the mask so that the secondside headgear portion extends between a second eye of the patient and asecond ear of the patient on a second side of the head of the patientopposite from the first side of the head of the patient when the mask isworn by the patient.
 22. The positive airway pressure system of claim21, wherein the headgear includes: a top headgear portion that bothconnects to the first headgear portion above the first ear of thepatient and connects to the second headgear portion above the second earof the patient when the mask is worn by the patient, and that passesover a top of the head of the patient when the mask is worn by thepatient; and a back headgear portion that both connects to the firstheadgear portion above the first ear of the patient and connects to thesecond headgear portion above the second ear of the patient when themask is worn by the patient, and that passes around a back of the headof the patient when the mask is worn by the patient.
 23. The positiveairway pressure system of claim 21, wherein the mask is shaped to notextend into nostrils of the patient when the mask is worn by thepatient.
 24. The positive airway pressure system of claim 23, whereinthe seal portion forms a nasal cradle, and the mask avoids contact witha nasal bridge region of the patient when the mask is worn by thepatient.
 25. The positive airway pressure system of claim 24, whereinthe first nostril engagement flap portion and the second nostrilengagement flap portion are angled with respect to each other in aV-shaped orientation at a first angle of about 75-95 degrees.
 26. Thepositive airway pressure system of claim 25, wherein: the seal portionincludes an annular supporting wall; the first nostril engagement flapportion extends away from the annular supporting wall; and the secondnostril engagement flap portion extends away from the annular supportingwall.
 26. The positive airway pressure system of claim 21, wherein: themask is connectable to an air-delivery conduit to receive pressurizedair through a second aperture that is spaced apart from the firstaperture, wherein the mask includes an interior surface between thefirst aperture and the second aperture that is in communication withpressurized air when pressurized air is provided to the mask from theair-delivery conduit; and the hanging flexible membrane is a continuousextension of the interior surface that is in communication withpressurized air when pressurized air is provided to the mask from theair-delivery conduit.
 27. The positive airway pressure system of claim26, wherein the first aperture has a width of about 15-40 mm.
 28. Thepositive airway pressure system of claim 27, wherein the first aperturehas a height of about 5-15 mm, the width of the first aperture beinggreater than the height of the first aperture.
 29. The positive airwaypressure system of claim 28, wherein a length of the nose tip engagementportion between the first aperture and a periphery of the hangingflexible membrane is about 12-18 mm.
 30. The positive airway pressuresystem of claim 21, wherein the seal portion includes a first stifferportion integrally formed with the first nostril engagement flap portionand a second stiffer portion integrally formed with the second nostrilengagement flap portion, each of the first stiffer portion and thesecond stiffer portion being more stiff than each of the nose tipengagement portion and the upper lip engagement portion.
 31. Thepositive airway pressure system of claim 30, wherein: the first stifferportion extends radially from the first aperture to a periphery of thehanging flexible membrane on the first side of the mask; and the secondstiffer portion extends radially from the first aperture to theperiphery of the hanging flexible membrane on the second side of themask.
 32. The positive airway pressure system of claim 31, wherein: thenose tip engagement portion includes a first flexible portion that isless stiff than each of the first stiffer portion and the second stifferportion, the first flexible portion extending radially from the firstaperture to the periphery of the seal portion; the upper lip engagementportion includes a second flexible portion that is less stiff than eachof the first stiffer portion and the second stiffer portion, the secondflexible portion extending radially from the first aperture to theperiphery of the seal portion; and each of the first flexible portionand the second flexible portion are located between the first stifferportion and the second stiffer portion.
 33. The positive airway pressuresystem of claim 30, wherein the first stiffer portion and the secondstiffer portion are more stiff than each of the nose tip engagementportion and the upper lip engagement portion due to both the firststiffer portion having a greater thickness than each of the nose tipengagement portion and the upper lip engagement portion and the secondstiffer portion having greater thickness than each of the nose tipengagement portion and the upper lip engagement portion.
 34. Thepositive airway pressure system of claim 30, wherein the hangingflexible membrane comprises varying materials, with the first stifferportion and the second stiffer portion comprising a harder material thanthe nose tip engagement portion and the upper lip engagement portion.35. The positive airway pressure system of claim 30, wherein: the firststiffer portion is located within the seal portion to seal with aportion of the nose of the patient adjacent a first nasal labial creaseof the patient when the mask is worn by the patient; and the secondstiffer portion is located within the seal portion to seal with aportion of the nose of the patient adjacent a second nasal labial creaseof the patient when the mask is worn by the patient.
 36. The positiveairway pressure system of claim 30, wherein: a thickness of the firststiffer portion is about 1-5 mm; and a thickness of the second stifferportion is about 1-5 mm.
 37. The positive airway pressure system ofclaim 36, wherein: the first stiffer portion has a radius of curvatureof between about 2.4 mm-6 mm; and the second stiffer portion has aradius of curvature of between about 2.4 mm-6 mm.
 38. The positiveairway pressure system of claim 30, wherein the first stiffer portionand the second stiffer portion define portions of the hanging flexiblemembrane having the greatest stiffness.
 39. The positive airway pressuresystem of claim 21, wherein: the first nostril engagement flap portionincludes a first integrally molded thickened region that is more rigidthan the nose-tip engagement portion; and the second nostril engagementflap portion includes a second integrally molded thickened region thatis more rigid than the nose-tip engagement portion.
 40. The positiveairway pressure system of claim 21, wherein: the mask includes a frameto which the seal portion is attached; the first side headgear portionis attachable to the mask at a first side of the frame; the second sideheadgear portion is attachable to the mask a second side of the frameopposite from the first side of the frame; the hanging flexible membraneis formed of silicone; and the frame is more rigid than the hangingflexible membrane and is formed of a material different from silicone.41. The positive airway pressure system of claim 21, wherein the mask isconnectable to a first air delivery conduit at the first side of themask and a second air delivery conduit at the second side of the mask.42. The positive airway pressure system of claim 21, wherein theheadgear includes means for connecting the first side headgear portionto the mask at the first side of the mask and means for connecting thesecond side headgear portion to the mask at the second side of the mask.43. The positive airway pressure system of claim 42, wherein the sealportion includes means for varying stiffness among different portions ofthe hanging flexible membrane.
 44. The positive airway pressure systemof claim 43, wherein the mask includes a frame that is more rigid thanthe hanging flexible membrane, and the mask includes means forconnecting the frame to the hanging flexible membrane.
 45. A positiveairway pressure system for treatment of sleep disordered breathing,comprising: a mask with a seal portion that is shaped to seal with aface of a patient around nares of the patient when the mask is worn bythe patient, the seal portion defining a first aperture to provide airfrom an interior of the mask to both nares of the patient, the maskbeing shaped to not extend into nostrils of the patient when the mask isworn by the patient and being shaped to avoid contact with a nasalbridge region of the patient, the mask defining a second aperture thatis spaced apart from the first aperture and through which the mask isadapted to receive pressurized air from an air-delivery conduit that isattachable to the mask at the second aperture, the mask including aninterior surface between the first aperture and the second aperture thatis in communication with pressurized air when pressurized air isprovided to the mask through the second aperture from the air-deliveryconduit, wherein the seal portion comprises a hanging flexible membranethat surrounds the first aperture and includes: a nose tip engagementportion shaped to contact a tip of a nose of the patient when the maskis worn by the patient and being flexible toward a distal portion of themask when the nose tip engagement portion contacts the nose of thepatient; an upper lip engagement portion shaped to contact an upper lipregion of the patient, a base of the nose of the patient, or both theupper lip region of the patient and the base of the nose of the patient;a first nostril engagement flap portion located between the nose tipengagement portion and the upper lip engagement portion on a first sideof the mask, the first nostril engagement flap portion including a firststiffer portion that is more stiff than the nose tip engagement portionand more stiff than the upper lip engagement portion; and a secondnostril engagement flap portion located between the nose tip engagementportion and the upper lip engagement portion on a second side of themask opposite from the first side of the mask, the second nostrilengagement flap portion including a second stiffer portion that is morestiff than the nose tip engagement portion and more stiff than the upperlip engagement portion, wherein the hanging flexible membrane is acontinuous extension of the interior surface that is in communicationwith pressurized air when pressurized air is provided to the mask fromthe air-delivery conduit; and headgear structured to maintain the maskin position on the face of the patient when the mask is worn by thepatient, the headgear including: a first side headgear portionattachable to the mask at the first side of the mask so that the firstside headgear portion extends between a first eye of the patient and afirst ear of the patient on a first side of a head of the patient whenthe mask is worn by the patient; a second side headgear portionattachable to the mask at the second side of the mask so that the secondside headgear portion extends between a second eye of the patient and asecond ear of the patient on a second side of the head of the patientopposite from the first side of the head of the patient when the mask isworn by the patient; a top headgear portion that both connects to thefirst headgear portion above the first ear of the patient and connectsto the second headgear portion above the second ear of the patient whenthe mask is worn by the patient, and that passes over a top of the headof the patient when the mask is worn by the patient; and a back headgearportion that both connects to the first headgear portion above the firstear of the patient and connects to the second headgear portion above thesecond ear of the patient when the mask is worn by the patient, and thatpasses around a back of the head of the patient when the mask is worn bythe patient.
 46. The positive airway pressure system of claim 45,wherein: the first stiffer portion extends radially from the firstaperture to a periphery of the hanging flexible membrane on the firstside of the mask; and the second stiffer portion extends radially fromthe first aperture to the periphery of the hanging flexible membrane onthe second side of the mask.